As the demand for expedited publications continues to rise, scientific publishers face growing pressure to balance speed of publication with rigour of review. Rapid publication timelines – once an exception – are becoming more common, with manuscripts moving from submission to publication in a matter of weeks rather than months. How can publishers uphold quality standards in compliance with industry guidelines under such time constraints? Following his involvement in the session ‘Sustaining publication quality in a fast-paced world’ at the 2025 ISMPP European meeting, The Publication Plan caught up with Sam Cavana, Head of Publishing Solutions at Taylor & Francis Group to find out. 

During the session ‘Sustaining publication quality in a fast-paced world’ at the 2025 ISMPP European meeting, we heard that fast-track publications are becoming increasingly common, with timelines shrinking significantly. What do you see as the key factors driving the uptake of fast-track publication options? 

We run a regular survey at Taylor & Francis to understand the key reasons for choosing accelerated publication. The primary reasons are:  

• to publish on novel topics to get the information out to the research community as quickly as possible  

• to hit key deadlines for publishing the work, eg, to impact key discussions scheduled with healthcare authorities, to present at a conference, to time it to coincide with other planned publications  

• to make the content available and accessible as quickly as possible when there is a direct impact on patient care 

• to obtain peer review comments as quickly as possible to enable extra time for discussion of revisions and other publication planning activities.  

Bringing a scientific manuscript from inception to publication is a complex process with many steps and contributors. How do publishers maintain the integrity and reliability of scientific literature when implementing fast-track publication processes? 

Taylor & Francis ensures that publication of all manuscripts, whether via the standard track or accelerated track, is of the same high quality, integrity, and reliability. Publishing on an accelerated route does not change any editorial processes, and we expect reviewers to spend just as much time carefully reviewing an accelerated manuscript as they would any other. The key differences are that reviewers are usually found more quickly for accelerated papers, those reviewers are given shorter deadlines to complete their review, and, once peer reviewed, editors will assess those papers more promptly to make a decision.   

“Publishing on an accelerated route does not change any editorial processes and we expect reviewers to spend just as much time carefully reviewing an accelerated manuscript as they would any other.” 

Beyond the publisher’s role, authors and industry scientists clearly have a key part to play in the process. What are some of the common pitfalls they encounter during fast-track publication development? What guidance would you offer to ensure a smooth experience?  

We would recommend that all content is complete at submission, with any authors available to provide responses in a timely manner. This includes at both revision and proof stage. Ensure decisions regarding copyright and open access are made up front, so there are no discussions that may delay timely publication. Don’t hesitate to contact the publisher if there are specific requirements, dates you need to publish by, or questions you need to ascertain prior to submission.

Emerging technologies like artificial intelligence (AI) and machine learning are beginning to influence various aspects of scientific publishing. Could technologies like these enhance the efficiency and effectiveness of peer review in fast-track publishing? 

Taylor & Francis is already using AI tools to help us match some submitted manuscripts with appropriate reviewers. Finding the right reviewers for a paper can be a time-consuming process, so this technology can really help to improve efficiency of the process. We also use specialist AI-powered tools like CrossRef Similarity Check and Image Twin to perform checks on submitted manuscripts, identifying potential cases of plagiarism or image manipulation for further investigation. Beyond this, Taylor & Francis doesn’t have plans to use AI in the actual reviewing of research articles, and editorial decisions will always be made by a human. Our AI policy is that reviewers and editors must not upload manuscripts they are reviewing to generative AI systems, as doing so may pose a risk to confidentiality and rightsholders’ intellectual property.  

“Finding the right reviewers for a paper can be a time-consuming process, so [AI] technology can really help to improve efficiency of the process.” 

 When publications move through peer review at an accelerated pace, maintaining reproducibility and transparency could be challenging. What measures are in place to promote these standards in research findings published through accelerated channels? How do publishers address potential ethical challenges that may arise from the pressure to publish rapidly, such as conflicts of interest or data integrity issues? 

All papers follow COPE, ICMJE, and GPP 2022 guidelines, this wouldn’t change based on the speed of review. All papers are subject to the same policies in accelerated publication as in traditional publication. Open research practices are a key element in the promotion of reproducibility and transparency. Our data sharing policies encourage researchers to deposit their data in a repository before submission, so the availability of these data shouldn’t be impacted by the speed of the review and publication process. Any conflicts of interest would be picked up in Taylor & Francis’ screening processes and data issues picked up in the peer review process. Publishing on an accelerated route does not change editorial decisions or impact the screening processes. 

Elsewhere at the ISMPP meeting you championed the role of video explainers in the dissemination of scientific information. With visual media gaining popularity – especially among younger healthcare professionals – is it possible to integrate enhanced publication content types into fast-track publications to enhance engagement and impact? 

Accelerated publication for video articles and abstracts is available. To ensure accelerated publication timelines are met, we suggest providing a storyboard at submission rather than the final video. If there are comments on the video, it may mean that the video will need to be recorded again.  

The Video Journal of Biomedicine offers an accelerated publication option for standalone video articles. This follows the same process as a traditional manuscript. With video articles or abstracts, make sure that the authors are aware that they need to be available for the revision of the storyboard and that after provisional acceptance of the storyboard, no editorial changes can be made once the video has been created.  If the authors are creating the video, ensure that you have all stakeholders aware of the timelines for the accelerated publication route, so no delays are introduced at this stage.  

Internally, we have seen extenders significantly increase views of an article, and we look forward to presenting our findings in a poster at the 21st Annual Meeting of ISMPP in Washington, DC. 

Looking ahead, how do you see fast-track scientific publishing evolving? What criteria should be used to determine when fast-tracking is appropriate – and when a more traditional timeline is the better option? 

Taylor & Francis has offered accelerated publication in a small list of biomedical titles for over 15 years, and we will be expanding this service to a few select titles in our Medicine & Health portfolio in 2025 to offer a wider range of options to our customers in the industry. Taylor & Francis doesn’t have any plans to introduce this service to journals within other subject areas. As for whether the standard or accelerated route is most appropriate for a paper, that decision will be one for the person or team planning the publication, be it a medical communications agency or pharmaceutical company, rather than us. Our role is to provide publishing options to the community and to ensure that the highest standards of publishing excellence are maintained.  

“Whether the standard or accelerated route is most appropriate for a paper, [is a] decision for the person or team planning the publication, be it a medical communications agency or pharmaceutical company” 

 Sam Cavana is Head of Publishing Solutions at Taylor & Francis Group and can be contacted via LinkedIn. All views and opinions expressed in this article are those of Sam Cavana and do not necessarily represent those of Taylor & Francis. 

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Peer review is fundamental to the evaluation of biomedical research, ensuring the rigour and credibility of published scientific findings. However, the system is under mounting pressure due to the sheer volume of research being conducted, and the quality and timeliness of research evaluation is increasingly at stake. Richard Sever, co-founder of the bioRxiv and medRxiv preprint servers, is at the forefront of efforts to innovate in this space. We spoke with Richard to discuss his vision for the future of peer review, exploring how preprints and evolving evaluation methods might address the challenges facing scientific publishing today.

You recently participated in a session on the future of peer review at the ISMPP Annual Meeting. Do you believe that the existing peer review model effectively meets the needs of the scientific community, particularly in biomedical and clinical research? If there is room for improvement, what are the main deficiencies of the current system and what can be done to address them?

“I do think there’s room for improvement. When we say peer review, often what we mean is a broader picture that includes the editorial and administrative checks that a journal does, as well as the formal review by peers. That’s where things vary a lot – there are some journals that are incredibly responsible and do a very good job, and we know that there are some where it’s peer review in name only, most obviously the predatory journals. But there’s a spectrum, so there’s a lot of opportunity to improve the process. Part of that might be making different choices for different types of article. For example, for papers where there’s patient involvement, there needs to be far more stringent scrutiny than for a basic research paper. Patient consent for publication, deidentification of patient data, you can’t really expect peer reviewers to do those kinds of checks; you expect the journal to do them. In recent years, I’ve become more concerned about these editorial checks than peer review per se, because opinions will differ on the quality of manuscripts and its clearly not the case that the three people who peer review a paper are a representative sample of everybody who could review it; however, the integrity checks that a journal performs may ultimately be more important. Different journals cover different subjects though, so maybe they can approach things differently. A journal dealing with a high volume of basic research papers, for example, may not need to worry as much about certain checks. This is where we start considering the benefits of peer review, and in some cases, it may be better done after publication, leading to a more multidimensional, ongoing process. On the other hand, for a vaccine study, you may want a very thorough peer review before it goes out into the world, depending on the results.”

“…there’s a lot of opportunity to improve peer review. Part of that might be making different choices for different types of article.”

You co-founded the medRxiv preprint server for health science research in 2019. How and where do preprint servers fit into the existing peer review model? Has that positioning evolved in the years since medRxiv was launched?

“The clear thing about preprint servers is that they’re decoupling research dissemination from research evaluation and specifically from peer review evaluation. What has become very clear both in the basic science space and in the clinical space is that you can do this so long as you responsibly put out preprints and make it clear that these are authors’ claims and they have not been verified. This is a good thing, because it acclimatises people to the fact that science can be a bit messy and just because somebody has put something out there, it doesn’t mean it’s necessarily valid. Preprints have demonstrated that you can do this decoupling, which then allows us to have a conversation about what the evaluation should look like. There are checks you can do very quickly at a preprint server: Does this paper look like it’s completely plagiarised? Does it seem completely unreasonable? Once those checks are done and the article is online, there’s more time to do a thorough review with less pressure. This is where the real opportunity lies for journals, and indeed new organisations that want to do peer review differently, to say “OK, the paper is out there, we are now going to evaluate it. Can we evaluate it in a better way because we haven’t had to rush the evaluation as the dissemination has already been achieved”.

“Preprints have demonstrated that you can decouple research evaluation from research dissemination.”

“In the 10 years since bioRxiv launched, we’ve had many different fields embracing this process and people understanding that you have to read the paper yourself; you can’t just take its conclusions on trust. It’s concentrated people’s minds in that respect, because we can all point to papers that apparently underwent ‘peer review’ but we’re aghast that they somehow made it through. What’s interesting is that the existence of bioRxiv is allowing people to begin to experiment with peer review. You now have organisations like Review Commons and Peer Community In, which are not journals; they are peer review services that operate based on the fact that there is already a preprint out there on bioRxiv or medRxiv.

The other thing we’ve certainly found at medRxiv is that you have to do this responsibly. There’s a small number of papers where the findings might influence public behaviour and we say these should go through peer review before dissemination, but that’s not true of 99% of clinical papers. That’s part of medRxiv’s initial screening, the obvious example being a paper claiming a life-saving treatment or vaccine was dangerous and a consequence of its dissemination could be that a lot of people stop taking the treatment – that would be a problem and we wouldn’t post it. But most papers aren’t in that category, and in the clinical space, the pandemic showed that epidemiology could be disseminated as preprints with huge benefit. For example the RECOVERY Trial showing dexamethasone was an effective treatment for severe COVID came out as a preprint on medRxiv many weeks before it appeared in the New England Journal of Medicine.”

Thinking specifically about pharmaceutical industry-sponsored biomedical research, how have pharmaceutical companies embraced the use of preprint servers for disseminating their research findings? Speed of dissemination of preprints was a notable benefit during the COVID-19 pandemic. What are the other motivations for industry to use preprint servers for research dissemination?

“To the credit of the pharmaceutical industry, some of them are trying to figure out whether this is something they can or should do. We did get industry-supported papers showing the effectiveness of the COVID vaccines against different variants and that type of thing during the pandemic. So industry can and should make use of preprint servers. Part of the hesitation is this question of ‘safe harbour’ and what seems not quite resolved in everybody’s minds is whether pharmaceutical companies can put out these sorts of studies under safe harbour. The preclinical studies, the very basic research, I think they’re happy with, but some people in the pharmaceutical industry are worried that if they put out a paper that seems to show a clinical effect as a preprint, then they might be accused of trying to use the preprint server as a way to get around peer review and get out publicity claiming that a treatment works.

Speed of dissemination is the number one motivation for using a preprint server; another motivation is that you can revise preprints. So you can put out a preprint, get some comments, and improve it so that when you do send it to a journal, it’s in much better shape. A lot of people have observed that their papers have had easier rides through peer review journals because they’d ironed out some of the kinks after getting feedback on the preprint. There may also be some papers where you’re just getting some information out there, a follow-up work, for example, that doesn’t need formal peer review, and this will instead come in the community discussion that happens afterwards. I think that’s a debate among the scientific and clinical community as to what percentage of papers fall into that category.”

What are the primary challenges associated with the submission of industry-sponsored research to preprint servers. There can often be considerations relating to proprietary data, regulatory considerations, and potential for misinformation when thinking about disseminating clinical studies for instance. How can these challenges be addressed?

“This is why I think it’s important that preprint servers have screening to eliminate or minimise the possibility of misinformation. There is a difference between a responsibly operated server like medRxiv and some databases that don’t screen at all. It’s also why we have more stringency in our screening checks on medRxiv than bioRxiv, because of these kinds of concern.

One of the benefits of the preprint server is that it doesn’t claim to have verified the information. I’m far more concerned about misinformation that appears in journals where there is a claim that the information has been peer reviewed, so a journalist then comes across it and assumes it’s been peer reviewed so it must be right. I often joke that the papers that claimed that COVID came from 5G towers were in so called peer-reviewed journals, and not preprints. If that sort of thing came into medRxiv, we wouldn’t post it.”

“I’m more concerned about misinformation that appears in journals where there is a claim that the information has been peer reviewed.”

Preprint review is gaining traction as an approach to evaluating scientific research before formal journal publication, and you’ve mentioned the advantages of decoupling research evaluation from dissemination. How best do you think preprint review can complement traditional journal peer review?

“One obvious way is that a journal that’s doing traditional peer review can factor in the other evaluations that are going on. Review Commons is an interesting example in that you post a paper on bioRxiv, then you can go to Review Commons, who will do the peer review, and then you can take those peer reviews to a journal. There’s also the approach that one of the PLoS journals took, where they were actively looking at comments sections of preprints and taking the discussion into account in their peer review evaluation. I would certainly do that if I were an editor – if you’re getting two or three people’s peer reviews of a paper but there’s lots of discussion about that paper online that seems well-informed, then of course you’d want to factor that into your judgement. In the early days of Twitter, there were a lot of very good discussions of scientific papers – it’s become more polluted in recent years – and that demonstrated the potential for self-organised research evaluation. We shouldn’t lose sight of the fact that that’s what we really mean by peer review. Sometimes we think of peer review as a very formal process done over a period of weeks operated by a journal, but really in the scientific sense, peer review is the scientific community discussing and evaluating work and debating its significance. So it all comes back to this idea of decoupling of research evaluation from dissemination and asking how can we do the evaluation better.”

“We shouldn’t lose sight of the fact that that’s what we really mean by peer review… …the scientific community discussing and evaluating work and debating its significance.”

Thinking about a decoupled approach to research evaluation, what do you think about a model whereby the medical societies commission their own peer reviews instead of the traditional journal peer review approach?

“One of the questions I would ask if you were a scientific or medical society considering creating a new journal tomorrow and you knew that all the papers were going to be on bioRxiv or medRxiv, is what’s the point in hosting the papers on a website if they’re already on a preprint server? You can just do the review part. This gets back to a phrase that some people have used to describe the future: Publish, Review, Curate. Scientific societies would be a perfectly positioned to do that – they have the expertise, and they are seen as working in the interests of the scientific community. The challenge as with so much of publishing is the business model and who pays, but that’s a challenge the entire industry is facing. At least the decoupling means that you don’t have to pay for the hosting and putting the papers online because that’s already been done.”

We recently featured a piece on eLife’s ‘reviewed preprint’ model and the journal’s experience from the first year, with faster research dissemination without a reduction in quality. Do you see eLife’s model as a blueprint for the future of biomedical publishing?

“The interesting thing about the new eLife model is that it confronts this issue of peer review being a seal of approval. The worry has always been that you send your paper to, say, the New England Journal of Medicine, they don’t think it’s good enough to publish, and so you just go down the chain until ultimately your paper gets published somewhere – it gets a ‘tick’ saying it’s peer reviewed. Does that mean it’s correct or good enough to publish? Clearly the journals higher up the chain didn’t think so. What the eLife model does is explicitly say peer review is a process, not a judgement. You go through eLife peer review, you get peer reviews, and those peer reviews might say the evidence basis is not sufficient for the claims made. In other words, what they mean by ‘peer reviewed’ is that there are peer reviews for this paper, not that they have decided to give the paper a tick or endorsement. It’s a very interesting – and polarising – idea, because it makes people consider the difference between peer review as a process and peer review as a certification. Again this comes back to the view that peer review doesn’t need to be the same for all papers. I could see large swathes of basic science operating like this and clearly some of the funders seem to be thinking along these lines. I find it harder to see it working for clinical research, because there I think people do feel like they want some kind of judgement as to the veracity of the work. So I’d be less likely to predict success of the eLife model in the clinical space. It probably only works if you ensure the Curate part of the Publish, Review, Curate model – there’s too much for people to read and they want a signal as to whether they should read something.”

“What the eLife model does is explicitly say peer review is a process, not a judgement.”

It’s inevitable with innovative approaches like preprints and preprint peer review that people can have some misconceptions and scepticism. Are there any misconceptions you would like to dispel?

“The notion that preprints and preprint servers are all incredibly irresponsible and it leads to all this misinformation coming out – that’s not true. That’s why we have screening and these ‘do no harm’ rules. When I look back at the pandemic as an example of this, I don’t see any big errors that were made by bioRxiv and medRxiv. I do see a lot of errors that were made at journals – the Surgisphere papers for example or papers that said COVID came from outer space. These sort of things were not coming out on bioRxiv and medRxiv. The infamous paper by Didier Raoult on hydroxychloroquine did appear as a medRxiv preprint, but within 24 hours of that it appeared in a journal as well, and that was the thing that everybody was pointing to. I wouldn’t want to blame any physicians, but in the fog of war, anecdotal reports of hydroxychloroquine, etc. meant there was a problem with misinformation there, but I don’t think we should point the finger at preprints for it.”

“The notion that preprints and preprint servers lead to misinformation coming out is not true.”

What other innovative approaches should we be considering to evolve the peer review process?

“I think you could have a number of different stages of review – so decoupling things even further and saying, for example, the person who looks at the statistics in a paper need not be the same person who looks at the biology. So we might get to a point where we can say somebody’s checked a dataset, somebody’s looked at the crystal structure, somebody’s looked at the stats, etc. – and peer review evolves to be more of a constellation of trust signals in which individual elements of the paper have been verified. This could be particularly important for multidisciplinary studies where it’s conceivable that no one person could read and understand the whole paper. More generally, we should acknowledge we have been far too dependent on papers as the indicator of somebody’s scientific contribution. There are people who write code, people who create databases and data resources, for example, and we should understand that the peer-reviewed paper is part of a broader constellation of academic outputs, some of which may never produce ‘papers’.

We could also consider the idea of separating out the technical checks of a manuscript from a contextual review, and maybe those things can be carried out by different people. That way we could involve more people in the peer review process. It’s frequently noted that the peer review process is buckling and straining and there aren’t enough peer reviewers, but there are lots of younger scientists who want to peer review papers, and maybe they can do some of the technical review and maybe the more experienced heads do some more contextual review.”

Can artificial intelligence (AI) help in the peer review process, or might it cause more problems?

“The short answer is both. It’s very clear that AI can help; we all use spelling and grammar checks, and particularly for non-native English speakers, the use of large language models to help improve their English seems like a no-brainer. There are lots of useful time-saving tools, but from the author’s perspective, you can’t take any of their outputs on trust. We’re happy to have ChatGPT help write your paper, but you should read what it’s written and make sure that you agree with it, because ultimately you as the author are responsible for the content. On the flip side, undoubtedly AI will be used by bad actors to try and fake stuff, and I think a lot of publishers are talking about the notion of an arms race between the papermills and the publishers as people try to identify content that is entirely automated and fake as opposed to things that have undergone language polishing or used a tool that helps you process your data.”

Reflecting on the journey of bioRxiv and medRxiv, what have been the most surprising or significant lessons learned about the role of preprints in scientific publishing?

“I don’t know if it was a surprise, but one thing that was very striking was the rapid adoption of medRxiv during the pandemic. There’s that saying “If you build it, they will come”, which I’m always very dismissive of because I see so many examples where people built things they thought were great and nobody came. But one of the lessons was that scientists do adopt things when they see clear benefits for themselves and the community. They were very quick to adopt email, for example, but less quick to adopt electronic notebooks. The experience with bioRxiv was that once people figured out what it was doing, a lot of them became converts because they saw it as a huge benefit to themselves as individuals, and also the community. We anticipated that medRxiv would have a slow adoption phase over five years or so before anybody really used it; then came the pandemic. We launched medRxiv in 2019 and we certainly hadn’t told anyone in China about it, but by Spring of 2020 when the pandemic started, we were getting dozens of papers every day from China. So it was amazing to see this brand new thing that didn’t exist even a year before the pandemic, suddenly have 10 million people looking at it every month.”

“It was amazing to see this brand new thing that didn’t exist even a year before the pandemic, suddenly have 10 million people looking at it every month.”

Finally, what is your vision for the future of peer review in medical publishing? It’s been just over ten years since the founding of bioRxiv. How do you see the landscape evolving over the next decade?

“What I would really hope – and we’re beginning to see signs of this – is that the funders of research see that preprints are a really easy way to address a problem that they’ve been trying to solve for 20 years: how to provide public access to research. We’ve talked about peer review and its complexity, but the challenge of public access is one that we can solve really easily by funders just saying, “Post a preprint”. That could solve the problem tomorrow. Some funders are getting close to that, like the Chan Zuckerberg Initiative, and the Michael J. Fox Foundation, and actually the Bill & Melinda Gates Foundation are now taking this kind of approach. So that would be my number one hope: that this solves the access problem.

“Preprints are a really easy way to address the problem of providing public access to research.”

The other thing I’d love to see a lot more of is experiments in peer review – both by journals and self-organised communities. There’s a real opportunity for everyone involved to decide how can we do peer review better. Decoupling will also hopefully get us away from conflation of questions like Should I read this paper? Is this person good? Is this work of general interest? This is currently all conflated in assumptions based on the journal where the paper appears, but you can have great work that’s not in the top journals and things that are really important aren’t necessarily of broad general interest. A post-preprint ecosystem is an opportunity to try and get away from the conflation.”

Richard Sever is Assistant Director of Cold Spring Harbor Laboratory Press, and the co-founder of bioRxiv and medRxiv and can be contacted via LinkedIn.

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Patients are regularly turning to the internet and social media to gain medical information or share their experiences, which has led to the relatively new concept of patient influencers. Following her participation at the 19^th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP), The Publication Plan spoke to Amrita Bhowmick, Chief Strategy Officer at Health Union and Adjunct Assistant Professor at UNC Gillings School of Global Public Health, to learn about the role of patient influencers and online communities and to find out how digital platforms can be used to increase patient engagement.

Health Union is a digital health company that develops condition-specific online communities. Could you tell us a bit more about the online community model at Health Union and how you went about developing it? What were the key considerations and the main challenges you encountered?

“At its core, our community model is focused on “meeting people where they are” in a way that provides information, validation, and support. Unlike many initiatives in healthcare, we aren’t looking to change patient behaviour – rather to provide social support, which is proven to have a positive impact on patient engagement, morbidity, and mortality. Our model puts patient leaders (or “patient influencers”) at the core of the community – ensuring that the communities are truly built for patients by patients.

Moderation is an essential ingredient for the communities’ success – our moderators have extensive training to ensure they are prepared to handle whatever may come their way in a clear, consistent, and transparent manner. This is an area of continuous improvement to ensure we are prepared to adapt as quickly as technology and online behaviours evolve. Maintaining a safe space for our members while encouraging engagement and transparency requires a very fine balance.”

Are you seeing an increase in the use of online health communities? Why are they such an important resource for patients?

“The internet and social media continue to play a growing role in how people engage with their health.”

“The activity level in our communities has increased consistently over time across all conditions. This is not surprising given the macro level data we’ve seen – the internet and social media continue to play a growing role in how people engage with their health. We know that 5% of all Google searches are now health related and one survey found that 60% of Gen Z respondents said social media influencers impacted their mental health decisions.”

At the Annual Meeting of ISMPP 2023 you talked about the value of patient engagement in health research. What do you think are the main benefits of involving patients throughout the drug development process?

“There are so many benefits to including patients in the drug development process –ranging from identifying a target product profile that truly meets the needs of patients to developing clinical trials with improved retention rates. Patients can also help ensure communications are clear and compelling, and can help with the trial recruitment process (particularly in the areas of communication, education, and reach).”

What more could be done by pharmaceutical companies, publishers, or others working within medical communications to encourage patient engagement?

“Engaging patients early in the process is the best way to truly drive patient engagement – ensuring that patient considerations are accounted for in every step of the process versus trying to retrofit to patient needs on the backend. Small changes that are easy to make up front (to patient-friendly language, for instance) can have a very meaningful impact on outcomes. These changes are often far more difficult to make later in the process.”

Plain language summaries are sometimes included in medical publications – how important do you think these are in disseminating information to patients?

“The more we can do to make health information accessible to patients, the better! Having patient leaders promote and explain these plain language summaries could further increase the reach and impact of the content.”

Do you think social media should be more widely used as a means of sharing medical information directly with patients? What are the potential challenges or risks involved in doing so and how should these be managed?

“Social media continues to play a critical role in how individuals consume content, including health information. Our “meet people where they are” model focuses on meeting people where they are in their health journey, but also focuses on meeting people where they are physically – this includes social media platforms to ensure we are as accessible as possible for our members.

Providing information in a clear and transparent way that is truly intended to engage with patients is the most effective way to encourage positive dialogue – authenticity and a willingness to engage are critical ingredients for success. However, it is important to be prepared for this engagement – plan for the questions/comments that may arise and have a shared agreement for how to handle these situations in a transparent manner.”

“Providing information in a clear and transparent way that is truly intended to engage with patients is the most effective way to encourage positive dialogue.”

The concept of “patient influencers” is relatively new. Could you explain what is meant by this term and describe the positive impact patient influencers can have within medical communications? What are the considerations regarding potential misinformation?

“While the concept of patient influencers is new, the idea of community leaders is not. For instance, public health officials have worked with community leaders (for example barbershops, beauty parlours, places of worship) to support educational initiatives for decades. Community leaders have established relationships with their constituents that are highly effective in driving effective communication and engagement.

Patient influencers can be viewed as the online version of these community leaders – respected leaders who build connections with their followers via their personal story and experiences. Our research shows that patient influencers are highly effective in communicating health information and can even increase self-efficacy.

Patient influencers typically distinguish themselves from the broader “influencer” industry as their focus is health- or disease state-specific. Our research shows that these individuals, who are aware of the misinformation pitfalls, value responsible communication and are very cautious not to provide medical advice. Providing clear guidance and training regarding a particular health program is the best way to ensure partners consistently communicate in the most accurate manner.”

How could technology play a bigger role or be better leveraged within the pharmaceutical or medical communications industries to encourage patient engagement or to communicate more effectively with patients?

 “Technology allows us to reach and engage with patients at a scale that has never been possible before.”

“Technology allows us to reach and engage with patients at a scale that has never been possible before. Leveraging the available tools can also help the healthcare industry identify and reach patients in a highly targeted manner – at scale. Engaging patients, or patient influencers, as part of the process for drug development and/or health communications will further increase the likelihood of success by ensuring the patient perspective is consistently in focus.”

Amrita Bhowmick is Chief Strategy Officer at Health Union and Adjunct Assistant Professor at UNC Gillings School of Global Public Health.  Amrita can be contacted via amritab@email.unc.edu or LinkedIn.

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There is growing appreciation of the benefits of patient involvement during the drug development process, from clinical trials to data dissemination and post-marketing activities. Consequently, patient involvement is increasingly being advocated in industry and journal policies and guidelines. Following her participation at the 2023 International Society for Medical Publication Professionals (ISMPP) EU meeting, The Publication Plan spoke to Christine Vanderlinden, Senior Director, Head Global Publications at GSK, to gain her insights on patient engagement within medical communications. Christine also discussed the latest update to the Good Publication Practice guidelines (GPP 2022), on which she was a co-author, and provided her thoughts on data dissemination and the use of social media within the pharmaceutical industry.

At the 2023 European Meeting of ISMPP you took part in a panel discussion which covered patient authorship of industry-sponsored publications. In your experience, what are the key benefits and challenges when involving patients as authors?

“Key benefits are addressing the needs of patients in scientific/medical publications and making complex scientific/medical content more understandable and accessible to an audience from diverse backgrounds. We can certainly demonstrate that patients and industry can work together in an effective way, while ensuring all ethical measures are in place. Enabling patients to directly report in a scientific manuscript their own personal experience to the medical and scientific community also increases confidence that publications address topics that have a real-world relevance. Finally, we provide a clear example of inclusion.”

“Enabling patients to directly report in a scientific manuscript their own personal experience to the medical and scientific community also increases confidence that publications address topics that have a real-world relevance.”

“Key challenges include ensuring the appropriateness of engaging patients as authors. This is an important consideration for companies looking to develop policies for working with patient authors and should be approached with a broader view of patient engagement at study level. We should also be very careful not to create the perception of engaging patients as authors to convey specific product messaging and we should ensure patient authors are fully engaged during the entire process of the publication to guarantee authorship.”

Patients may contribute to many aspects of the publication process, including but not limited to contributing as an author. For example, they may review materials or help to design clinical studies. Could you describe your experiences of working with patients in these or other roles? What are your key learnings from such experiences?

“Patient engagement should not be considered in silo for one activity but should be looked at from a broader perspective ie, considering the patient engagement journey as an end-to end activity from study design to publications. Considerations for patient engagement can also differ between therapy areas and different approaches may be required for example in rare diseases, and for therapeutic treatments versus prophylactic treatments. Patients as reviewers either of a whole publication or of a plain language summary included in a publication bring rich insights and make the research more tangible and accessible from an end-use perspective.”

“Patients as reviewers either of a whole publication or of a plain language summary included in a publication bring rich insights.”

The guidance in GPP 2022 surrounding compensation of patient participants and patient advocates is clear and does not preclude offering compensation for involvement with publications activities. Is this sufficient and/or should there be more guidance to industry in this area?

“This area is still very new overall in the publication world and each company needs to conduct their own risk assessment and determine their approach towards this topic. As such, patient authors should not be considered differently from other authors and any compensation needs to be aligned with the overall approach of each company and follow transparency principles.”

“Patient authors should not be considered differently from other authors and any compensation needs to be aligned with the overall approach of each company.”

At the 2023 European Meeting of ISMPP, you also discussed the use of independent platforms such as Figshare and industry-owned platforms for disseminating research. Could you briefly share your thoughts on the pros and cons of each of these platforms for sharing content? Does GSK currently use either method?

“I believe that accessibility of publications and publication content is key. Some of these platforms can be an interesting way to increase that accessibility by increasing the entry points to a publication and therefore increasing its discoverability. The downside of this is that we need to ensure full transparency and decrease complexity by linking all of the outputs generated from each data set/piece of research.

GSK is not systematically using Figshare for all publications but is using the platform to post publications enhancements when journals do not provide the option of hosting such content. In those cases, a link to the Figshare post is included in the main publication. Some journals also use the platforms to post appendixes and additional materials to the main publication.”

Thinking more broadly about data dissemination, what are your key considerations when making publication decisions with regards to publishing open access or using enhanced features such as plain language summaries or graphical or video abstracts?

“Our main considerations are linked to making the research data more discoverable, accessible, and understandable by the key target audiences and also making it more accessible for broader audiences and use. On the content of the publications itself, we need to specifically focus on the language use, the style, the way to present the information, the importance of visuals and podcasts to be considerate of this broad usually non-scientific, non-medical audience.”

“We need to specifically focus on the language use, the style, the way to present the information, [and ] the importance of visuals and podcasts…”

Has the GPP 2022 update or your involvement in its development changed your approach to any publication-related processes? Which aspects of the guidelines do you think will have the most impact on daily working practices?

“The GPP 2022 update has not changed my approach to publications related processes overall. None of the principles of GPP3 have been modified in GPP 2022. GPP 2022 is mainly focussed on new emerging trends and provides guidance and insights on those topics. For instance, I believe that the recommendations on patient involvement will support companies to align on this topic and encourage them to further develop patient engagement in research and research data communication.”

Do you feel social media should have a greater role within the medical communications industry, and if so, in which areas? Do you feel the mention of social media in the GPP 2022 update will encourage its use or is further guidance needed?

“Social media is fully embedded in our societal habits, including in scientific and medical communities. So, the use of social medial platforms needs to be considered carefully. Social media is a sensitive topic as it is subject to local regulations and there is a thin line in perception between what is considered scientific communication and what constitutes promotional activity. Hence why I believe that social media policies should remain in the scope of the external communication departments of companies who have a broader view and in-depth understanding of regulations in this regard and of journals who disseminate publications in a neutral way. GPP 2022 is not encouraging the use of social media for publication dissemination but rather deferring to the approach of individual companies as part of the broader topic of use of social media in external communications.”

Are there any new topics or areas which you feel could be expanded further in future iterations of GPP?

“I believe that with the rapid evolution and expansion of artificial intelligence, this topic will need more attention in the next iteration of GPP to provide aligned guidance and standard approaches in this field.”

Christine Vanderlinden is Senior Director, Head Global Publications at GSK and can be contacted via LinkedIn

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Increasingly pharmaceutical companies and medical publishers are drawing on the valuable insights and first-hand experiences of patient advocates when developing therapies and reporting medical research. Following his presentation at the 2023 Annual Meeting of the International Society for Medical Publication Professionals (ISMPP), The Publication Plan spoke with Patrick Gee, a patient advocate who is passionate about striving to achieve equitable healthcare access. Patrick describes his background as a patient with diabetic kidney disease and talks about his continuing mission to spread hope to others though his role as a patient advocate. Patrick is the Founder of iAdvocate and is also an Ordained Minister.

Could you tell us a bit about your background? Did any specific experiences of being a patient with diabetic kidney disease prompt your decision to become a patient advocate?

“My background is in justice, law and criminology. In 2003, whilst I was at work, I was feeling a bit sluggish and it was recommended that I go to the emergency room after the nurse took my glucose level and it was 758 mg/dL. In the emergency room they performed a blood test, the A1C, which was 11.7%, and it was then that I was diagnosed with having type 2 diabetes and was referred to an endocrinologist. Then 10 years later, in April 2013, during a routine doctor’s appointment, I was told that I was currently at stage 3b of end stage renal disease and I hadn’t a clue what that meant. In the ten years during which I had been treated for diabetes, I had never been told that the condition was the leading cause of kidney disease, so to hear that I was at stage 3b, when I didn’t know anything about any stages really caught me off guard. I was also told that my kidney function was between 30 to 35%, and again I didn’t know anything about the functionality of a kidney. So I was dumbfounded, I didn’t know how to interpret what I was being told, and I certainly didn’t know how to go home and explain it to my family. I was referred to a nephrologist, who told me that I would eventually need dialysis and would go into kidney failure, but at that time I just needed to abstain from chocolate, nuts and dairy products to slow down the progression. I had gained around 150 pounds in weight because my kidney function was declining kind of fast and I wasn’t able to pass all of the toxins out of my body, so on December 1^st, 2013, I underwent my very first exchange of peritoneal dialysis. After being told that I had lost my kidney function due to diabetes, my main reason for wanting to be an advocate was to be able to go out into the community and to be able to talk about health literacy because I had no information prior to my diagnosis. I wanted to target at-risk communities and rural communities who hadn’t been given any medical information on particular disease states. So my advocacy kind of launched from my diagnosis and that’s where I have been ever since.”

“My main reason for wanting to be an advocate was to be able to go out into the community and to be able to talk about health literacy because I had no information prior to my diagnosis”

At the 2023 ISMPP Annual Meeting you referred to your work as a BMJ patient partner. Could you describe what this role involves in terms of authorship and peer review? How are BMJ and other publishers driving advances with this type of initiative?

“In 2018 I was asked to participate in an international study about different therapies and drug innovations pertaining to the management of type 2 diabetes. I believe I was one of five patients out of maybe 15 people on this particular committee and we were looking at all of the different research on sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) agonists, and even some other medications like metformin. We were really giving a patient perspective based on how the research was explained and what we thought would benefit us not only individually but as a collective. That particular process with BMJ was great because I knew the prominence of the BMJ and was excited to be able to participate in such a great publication. They couldn’t offer an honorarium but could make me a co-author and to me that was like somebody going to the Oscars and winning the award for supporting actor. To me co-authorship was better than money because of the prominence. Throughout the process we were not seen as weak, afflicted or even subservient, but we were actually made to feel like partners, like equals, so all of us had an equal say and there was even more emphasis on what we had to say. If we didn’t understand anything, the study team would stop and take their time to explain it, so it was really a great opportunity. It was at that point that I really learned to appreciate how the patients’ perspective can go towards helping industry, medical providers, scientists, and clinical trialists in understanding certain product developments or particular therapies.”

Why is it so important for pharma companies and medical publishers to involve patients when reporting medical research? What are the main barriers to patient involvement in this area and how can these be overcome?

“In my personal and professional opinion, I believe that the reason that pharma companies should include patients is because we are the end users. We can share our lived experiences and describe how some of these therapies and technologies actually work, some of the pros and the cons, the benefits and some of the things that really need to be worked on, such as side effects. We know there is no such thing as the perfect therapy but as patients or end users we can tolerate certain things when we can better understand them. As patients partnering with pharmaceutical companies, we can share our lived experiences but maybe some of our gifts and talents in other areas can add to the design of the technologies. We are also able to go back out into the communities to explain medical research, help clinicians, community health workers and even educate those that may be in the same disease state to better understand how pharmaceuticals work. We can help break down the barriers when it comes to ensuring that clinical trial partnership or recruitment is more diverse and inclusive to everyone. One of the biggest barriers is fear, and that’s on both sides. From the pharmaceutical companies there is the fear of not knowing how to talk to their consumers in a manner that doesn’t suggest they are trying to recruit them. I know the pharmaceutical companies that I work with are now very community minded. They know that in order to be able to engage the public they have to literally become a part of the community – they take the time to understand the needs of the communities, the needs of those who will use their therapies. They understand that it is more than just the therapies that need to be considered, but how a person lives, the affordability of the therapies, whether the patient has insurance and if they don’t have insurance how pharmaceutical companies can work with insurers to ensure the patient has access to the product. From the patient standpoint, because of a lack of diversity when it comes to clinical trials you have conspiracy theorists that always want to put things out there and they scare the public. Right now I believe with patient ambassadors, professional patients and advocates being able to go out and knock down those barriers, we can better help people to understand that working with pharmaceutical companies will not only help them but will also help their family at some point, down the generations, to be able to receive better medications, better treatment, better healthcare outcomes and overall better quality of life.”

“Pharma companies should include patients because we are the end users and we can share our lived experiences”

Plain language summaries (PLS) are recommended in the latest Good Publication Practice guidelines. How important do you think these are in disseminating medical research to patients? Are there any other formats that you think should be more widely used to ensure that patients are able to access the information they need?

“It wasn’t until I went to the ISMPP annual meeting that I really understood PLS even though I had written articles. Even the journals I wrote for never really explained them to me. Sometimes when journals ask for a patient perspective, they actually want patients to write in medical terminology that they are not familiar with. When PLS were explained to me a light bulb went off, because as a patient advocate I don’t understand all of the medical terminology and jargon as a lot of these things are complex, but when you put them in plain language, they are so much easier to read, to articulate, and understand, which allows dialogue with other non-healthcare professionals. PLS allow topics to be discussed with communities, who can share their opinions, which can then be taken back to healthcare workers and those in the industry. I really wish internationally that everyone would utilise this concept ─ I know that is a hard thing for people to do, but the annual meeting really opened my eyes. As a first-time attendee and as a patient, I was able to understand an entire conference without having to nudge a doctor to ask them to explain what was being presented. I felt that I was valued ─ they knew I wasn’t a physician, they knew that I was a patient, but they valued me enough to simplify information in a manner, which meant that the integrity was not lost, but everybody in the room understood the message, the need, and how we could all collaborate in this particular venture.”

“a lot of these things are complex, but when you put them in plain language, they are so much easier to read, to articulate, and to understand, which allows dialogue with other non-healthcare professionals”

You have a background in law, another area in which a lot of jargon is used and precise use of language is important. Does your expertise and experience in that area resonate with thinking about PLS in medical communications?

“After the ISMPP meeting, I was sitting on one particular advisory board and we were told we needed to write a white paper. I brought up PLS but got a lot of push back, so I said, OK, everybody in here has a medical degree but I’m the only one here with a law degree. I started throwing out law jargon and asked if they understood what I was saying. They asked how that was relevant, which illustrated my point. I was there as a partner, as an ambassador but they wouldn’t simplify the information. If they asked me to break down the legal jargon and explain it to them, I would be more than happy to do so. I said if you really want to understand how to break down that barrier of patient-physician or patient-provider communication, its plain language. I don’t know why for some people plain language is a curse word, perhaps those in academia have got so prestigious that they just don’t know how to communicate with the lay person. This also goes back to how you can better understand the patients that you care for ─ PLS meet us where we are, especially if we are trying to understand how to manage our disease state. In health literacy, we are using plain language when going into communities to explain about diabetes, kidney disease, or cancer so why can’t it be used in medical publications? That would be my question.”

When and how do you think it would be appropriate to use social media to share medical research with patients?

“Researchers and those trying to recruit for clinical trials or talking about medical innovations often use social media. In some aspects social media can be very good because it allows the public to stay abreast of new innovations and new technologies. The risk comes when you are dealing with negative comments as people often don’t know the difference between destructive and constructive criticism. I think the wording used is important ─ how will you get the biggest bang for your buck. You need to take the time to explain what it is you’re trying to do and understand that with social media you only have a limited amount of space to be able to talk in depth. A link or a QR code could be used to allow people to look into things further. I think in the age of social media, it has been really good at getting information out there, and allowing people to be reached who might not have known about but may be very interested in what you are posting. It allows them to access news and allows the news to be shared within communities and network so everyone can benefit from it.”

“social media can be very good because it allows the public to stay abreast of new innovations and new technologies. The risk comes when you are dealing with negative comments”

 You have talked about the need to ensure that everyone receives equitable treatment, and use the motto “I am the Voice of the Voiceless and Face of the Faceless in the fight against kidney disease.” What are the main issues you have encountered in terms of inequity within healthcare?

“When we talk about health equity there are a lot of things that are left out. Normally when people talk about health equity they are thinking about race or ethnicity. We know that race is not biological but a social construct, and when you look at ethnic minoritised groups, they are often left out due to systemic issues, not only in the United States but all over the world. What we fail to include when thinking about health equity is people over the age of 65 years, people living with disabilities, and people from the LGBTQ+ communities. Society seems to pick on women even though there are more women in this world than men. Yet women tend to be lumped into a minoritised group and there is a lack of balance and equality when it comes to the treatment of women. When you think about gender and other issues, there is a big void in the medical community for equal treatment and access to clinical trials, access to health literacy and access to a better quality of life, and these are the things that I’m very vocal and passionate about. I like to refer to the Universal Declaration of Human Rights, written by the United Nations in December 1948, which includes 30 articles outlining basic rights for human beings. We want to talk race and there is only one race and that’s the human race. If we can get back to that and just talk about human beings and understand that all human beings need to have a seat at the table, need to be treated equally, need to have access to medical innovations, drug development, and biologics, and need to have better care, especially those who are seniors or elders. Even when you look at our children there is a lack of diversity in paediatric care, especially if you look at the mortality rates in maternal health. So there are a number of things that I am very passionate about. If we could just treat people as human beings and stop looking at their exterior but instead look at their heart and the need to serve each other, I think we could certainly eradicate a lot of the current problems within the healthcare system.”

“all human beings need to have a seat at the table, need to be treated equally, need to have access to medical innovations, drug development, and biologics, and need to have better care”

You gave the 2023 ISMPP Annual Meeting your ‘award’ for the most inspiring or transformative patient partnership initiative. What can ISMPP and the wider medical communications industry do to improve equity and inclusivity?

“I think outside the United States they are doing an excellent job, especially with patient engagement. In the United States I think maybe there is an issue of not being widely known among patient groups. My advocacy isn’t just in kidney disease, it also covers diabetes and heart disease. I’ve not heard about ISMPP through the different societies that I work in when it comes to publications, and I had never heard of them before they reached out ahead of the annual meeting. Once I had been invited to the annual meeting I wanted to start letting people know about ISMPP, and the more patients that I’ve told, the broader the outreach has been. As patients, we are very limited in who invites us to be able to share our perspectives, but now I feel that if I am not listened to, I will reach out to this organisation that has ties around the world – if people don’t want to hear what I’ve got to say locally in the United States, then I will go and share my perspectives with like-minded people in other countries and we can come together as one. I think ISMPP could gain a bigger audience if it was to become more present and more vocal among patient groups in the United States. I guarantee that more patients will jump on board to share their perspectives, because I’ve discussed ISMPP with some of my peers they are excited and want to learn more.”

Which of the activities that you have been involved with as a patient advocate have you found the most rewarding and why?

“One of my activities that I find very rewarding is being a minister. If you look at the definition of minister from Hebrew and Greek, it means to serve. I love going into the community, meeting people where they are, whether they are in a dialysis centre, in the emergency room, a hospital room, a nursing home, a coffee shop, wherever they are, even in church sometimes, I meet people where they are. I’m a very good listener so I listen to what people say but I also pay attention to what they don’t say. When it comes to health literacy, I explain that I’m not a physician but because I work in a number of organisations and committees I can get information, not just in this country but from researchers around the world to help patients make better decisions when they go to the doctor – they can talk about the research and ask how a certain therapy can help them. I consider myself a hope dealer – I deal hope, and in dealing hope I get to understand things from communities and take that back to industry. That’s probably the most rewarding part of my advocacy, meeting people where they are and being with them in that moment and staying with them until they recover or they feel they can manage – for me that’s the most rewarding thing about what I do.”

Finally, what advice would you give to any patients who are interested in acting as a patient advocate or collaborating with medical publishers or pharma companies?

“The first thing I would say is understand your particular medical journey and understand that your medical journey is totally different to what someone else is going through, even though it may be in the same disease state. Understand that your story is important and how you are able to convey that is very important, especially when you talk to people in the medical industry. I would also tell those that are interested in becoming advocates, to make sure that they pick a particular path. Some people are more diverse in crossing over into different areas, whereas some people just want to stay focused in one particular area. It’s important to understand that in our advocacy, we can’t be selfish – my work is not about me, it’s about those who are suffering like me or suffering more than me. Being an advocate is not about being selfish it’s about fighting for justice and you have to know which justice you want to fight for. For me, as I stated, I’m fighting to remove all of the racial and social, even cultural barriers, so human beings can just be human beings – living, breathing human beings who may be going through certain trials or tribulations or afflictions and who need care, love and somebody there to support them. That’s what I would tell new and up and coming patient advocates.”

Patrick Gee is Founder of iAdvocate and can be contacted via geepatrick50@yahoo.com or LinkedIn.

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Jonathan Lee is Senior Manager, Regional Publications, Growth and Emerging Markets at Takeda Pharmaceuticals and the Asia Pacific Trustee on the International Society for Medical Publication Professionals (ISMPP) Board of Trustees. The views expressed here are those of the interviewee and do not necessarily reflect those of Takeda Pharmaceuticals or ISMPP.

When developing a medical communications strategy, understanding the needs of colleagues from different geographic regions is key to ensuring plans are relevant and usable by all stakeholders. Effective publication planning therefore requires publication professionals to have an appreciation of cultural and linguistic diversity to recognise how to adapt and optimise engagement with publications teams and authors at a local level. Following his presentation at the 2023 Annual Meeting of ISMPP, The Publication Plan spoke with Jonathan Lee, Senior Manager, Regional Publications, Growth and Emerging Markets at Takeda Pharmaceuticals and current Asia Pacific Trustee for the ISMPP Board of Trustees to find out more about the role of publication professionals in regional publication planning.

You’re a big advocate for the importance of medical publication professionals in regional publication planning. Can you explain why this is such an important role; what are the potential benefits to industry-funded biomedical research in eg, Asia-Pacific (APAC) and Latin America (LATAM)?

“We’ve seen from many sources of research that our ethnic and geographic backgrounds can influence how we respond to certain treatments (eg, cancer treatments); however, efforts to better capture such diversity in current clinical trials will take time to be fully realised. A lack of sufficient ethnic/geographic diversity impacts the generalisability of clinical trial results to the under-represented groups in the general population. Additionally, healthcare systems can vary greatly across APAC and LATAM, so international treatment guidelines may not be fully applicable or implementable in some countries in these regions. This very often results in a lack of local/regional data and/or guidelines to support physicians with clinical decision-making relative to physicians in countries that tend to have good representation in clinical trials. A lack of resources in some countries in APAC and LATAM can also be a barrier to the conduct of clinical trials in these regions. This underlines the importance of having relevant local/regional real-world evidence to support clinical decision-making. But real-world evidence can be more challenging to publish than clinical trial data, given the differences in the nature of such studies.

This is where the importance of medical publication professionals comes in. Of course, we need people who can effectively design and execute such studies, but there is a saying that while a good publication cannot improve low-quality data, a low-quality publication can make great data look bad. Given the general lack of relevant local data, you can see how important it is to ensure that any data that are generated get published and disseminated in an effective manner across all regions. Think about the number of lives that could be impacted by the publication of important real-world evidence, like drug safety and effectiveness. This impact becomes even more pronounced in countries that may not use English as a first language (eg, many of the countries within Southeast Asia).

Therefore, it is critical that barriers to the publication of clinical data from regions like APAC and LATAM are removed or lowered. In order to implement such an initiative effectively, we need to have medical publication professionals who understand local and regional cultural and communication norms and who are well-versed with industry best practice. It’s not an easy combination to find.”

“We need to have medical publication professionals who understand local/regional cultural and communication norms and who are well-versed with industry best practice.”

You spoke at the 2023 ISMPP Annual Meeting and gave your insights into the role of publications professionals in the APAC region. What are some of the challenges to implementing global publication guidelines in a regional setting; how can publication professionals help to guide best practice?

“I think one of the biggest challenges is the assumption that all authors around the world are equally comfortable with sharing individual opinions, particularly differing opinions, in an open group setting. This does not always apply in cultures that favour group consensus and avoidance of confrontation over individual opinions and acceptance of open disagreement. Many countries in APAC (and other parts of the world) tend to have such consensus-seeking cultures. Some of these countries may also place more emphasis on hierarchy as a mark of respect, so open disagreement with a person who is considered senior to you is frowned upon.

Based on this you can then see how it may be challenging to collect individual inputs from a group of authors in an open forum in APAC. There is a tendency to wait for the most senior person to provide their thoughts first, before the rest of the group agrees as a mark of respect. Even if authors have differing opinions, they are unlikely to voice them.

A publication professional who understands this culture would know that soliciting individual opinions from such authors would be better done in an individual and personalised manner. Writing to or reaching out individually to authors would provide them with a safe space to express their opinions without fear of open disagreement with their colleagues. This individualised approach is even more important if the authors are not especially fluent in English. They may not be able to properly articulate their ideas in a language they do not regularly use and may also not want to appear foolish in front of their peers. Individually collected feedback could then be compiled and anonymised, so that all opinions can be reviewed without linking specific comments to individuals.

Separately, some cultures in APAC may favour face-to-face interactions or conversations over written responses – especially if you need to think in one language and then translate and articulate your thoughts in another language (consider the extra time required). While current practice and publication management systems rely on written documentation, authors in APAC may be more inclined to provide their thoughts through a conversation. Without a system that allows for documentation of such inputs, think about the amount of valuable clinical insights we may be missing because an author is unaccustomed to penning their thoughts or is unable to articulate them properly in English.”

“Think about the amount of valuable clinical insights we may be missing because an author is unaccustomed to penning their thoughts or is unable to articulate them properly in English.”

We’ve seen the Good Publication Practice (GPP) 2022 guidelines translated into Chinese and Japanese. Do you think translation of GPP and other guidelines such as EQUATOR checklists is sufficient or do the guidelines themselves need to be adapted on a region-by-region basis to account for different cultural norms?

“Translations are a good first step, but I think they need to be adapted on a region-by-region basis for the reasons I’ve described above. A translation is a literal interpretation of the original document that retains the cultural context of the language it was first written in. While it would be helpful to understand principles, the translated document may still struggle to communicate underlying concepts across cultures, so uptake of such guidelines may remain low. It’s analogous to global clinical treatment guidelines – can the recommended treatment sequencing still be implemented if some of the treatments are unavailable in your local healthcare system? This was one of the motivations for drafting the APAC adaptations of GPP3 and GPP 2022.

Adoption of guidelines by regional and local journals would also influence author receptiveness to guidelines. This would provide an additional avenue of encouragement and influence for authors to be familiar with and adhere to guidelines and best practice.”

You’re a co-author on the recent Asia-Pacific-adaptation of the GPP 2022 guidelines published in Curr Med Res Opin. How did you and your co-authors approach the task of producing this guidance? What were the most important updates in GPP 2022 from an APAC perspective?

“I’d like to first recognise the efforts of the authors of the APAC adaptation of GPP3, particularly Blair Hesp, who spearheaded the initiative. Development of the APAC adaptation of GPP3 was prompted by a need to provide clarity on how recommendations in GPP3 could be practically implemented within the context of the cultural and communication norms of the region. With the development of GPP 2022, which had several significant changes, it was only natural that these updated guidelines would need unpacking for the APAC region.

One of the more important updates was on how summaries of medical research written for non-specialist and lay audiences (ie, plain language summaries; PLS) can be utilised in the region. There is no doubt to the value that PLS bring to a publication in terms of improving accessibility to data, but not all regional/local journals are currently set up to accept such materials. Authors and audiences in APAC may also be less familiar with such content. Coupled with the smaller budgets that regional/local publication teams may have, decisions on the development of PLS need to be very targeted to ensure that the content will be accessible enough to readers and not buried in a supplementary file. As regional and local journals start to support the publication of PLS, clear guidelines on the development and review processes of such content will be instrumental in encouraging their development by authors.

“As regional and local journals start to support the publication of PLS, clear guidelines on the development and review processes of such content will be instrumental in encouraging their development by authors.”

Two other important updates were the commentary on the inclusion of patient authors and considerations for encore presentations at congresses. While the inclusion of patient authors is an important step towards a more holistic approach to biomedical research and drug development, the cultural landscape in APAC can add additional considerations. Physicians are often seen as senior figures to patients, so patients may be reluctant to share their opinions and physicians may perceive certain patient feedback as potentially undermining their expertise and therefore a source of embarrassment. There may also be situations where it would be culturally undesirable to be identified as being unwell – this may impact both the patient and their immediate and extended family.

On the topic of encores, there is a need for regional and local congresses to include clear guidance on their individual encore policies. Not all physicians may be able to attend international congresses, so encores provide an opportunity for them to still access important updates in biomedical research, more so if the encore is presented in a local language. Such increased access to data ultimately benefits patients who rely on their physicians to make important treatment decisions based on what they know.”

You also spoke at ISMPP about how the reliance on English as the default language of medical publications can be a participation barrier for non-native English speakers. What are some ways we can remove this barrier and what are the benefits if we can make participation easier?

“There are several things I can think of:

• Inclusion of English captions in videos will help to provide visual alternatives for people who may have challenges understanding and following various accents. The ability to provide real-time translations with artificial intelligence (AI), even if not completely accurate, would make presentations easier to follow.
• Provision of anonymised question posting platforms at congresses may encourage more questions from non-native English speakers. More so if there were options to post in your own language and then have it translated into English.
• AI-supported translations of publications may help non-English speakers access information that they would not normally have. AI-supported search algorithms could also help to better identify publications in various languages and make manuscripts more accessible through search engine optimisation.
• Having publication professionals and medical affairs representatives who are bilingual would allow for authors to provide input in the language they are most comfortable with. This would also allow their input to be accurately translated into English without losing any nuance and would go a long way to improving author engagement.
• Consideration of longer timelines by industry sponsors and journal editors to accommodate the need for face-to-face interactions and/or translations.

The benefit of lowering or removing these barriers is the improved sharing of ideas and information to support patient care. Imagine if a physician in APAC has a wealth of experience with treating patients in a particular setting that physicians from outside the region are trying to learn more about. But the APAC physician has never shared this experience because there is a challenge in communicating this in English. If communication in English was removed as a barrier, imagine how much more we might be able to do for patients with new-found access to previously untapped sources of knowledge!”

“The benefit of lowering or removing (participation barriers for non-native English speakers) is the improved sharing of ideas and information to support patient care.”

Is there a role for machine translation and/or generative AI tools to assist non-native English speakers with the publication process? What do you think could be done to encourage more biomedical research being published in multiple languages? Is mandatory multi-lingual publication of industry-funded biomedical research a goal to strive for?

“I’ve touched a little on this in the previous question. Building on that, I think it will be a practical question of how to balance the added time and resource costs of publishing in multiple languages versus the anticipated benefits. Idealistically, it’s a no-brainer if it benefits patients. Realistically, it would be challenging to mandate publishing in multiple languages if it is not financially viable.

Lancet Global Health has started supporting the publication of translated abstracts alongside the English version of accepted manuscripts, and I think this is a great step in the right direction. If the translated abstracts improve searchability of the manuscript in other languages, it will already start to make a positive difference in improving access to industry-funded biomedical research.”

“Lancet Global Health has started supporting the publication of translated abstracts… … If the translated abstracts improve searchability of the manuscript in other languages, it will already start to make a positive difference in improving access to industry-funded biomedical research.”

We’ve seen a continued focus on plain English language content in the biomedical publications community over recent years. Presumably, plain language content in languages other than English would be beneficial for non-native English-speaking patients, carers, and healthcare providers? Do you think there’s enough provision for this in the biomedical publishing industry?

“There is definitely a benefit to having plain language content in multiple languages. However, it comes back to the challenges of regional/local industry teams having smaller publication budgets to support the development of such content and the ability of regional/local journals and publishers to support publication of such content. I think we will need to watch how the global uptake and development of plain language content progresses further before the movement trickles down to regional teams and journals.”

Elsewhere at the 2023 ISMPP Annual Meeting, we heard how ISMPP’s geographic base continues to widen into new territories, with increasing numbers of Certified Medical Publication Professionals outside of North America and Europe. How else do you think ISMPP (and/or other professional societies involved in medical publishing) can evolve to increase the relevance of publications professionals in APAC and other regions?

“The biomedical publication landscape in APAC is a little different from that of North America and Europe. The major centres of industry-funded biomedical research reside in the large markets of Japan and China, while the major concentrations of medical writers reside in Singapore, India, Australia, and New Zealand.

We can all agree on the value of face-to-face interactions with publication professional peers, as seen with the record turnout we had for the 2023 ISMPP Annual Meeting, but the challenge in APAC is how to bridge the geographic space between the research centres and medical writers. Generally, smaller budgets for industry and agency teams in the region present major challenges for travel to regional congresses. For example, a congress held in Singapore (the geographic mid-point of the region) would still require a 5–7-hour flight from Australia, 7 hours from Japan, 5 hours from China, 4 hours from India, and 10 hours from New Zealand.

So, it remains a chicken-and-egg situation. Should the stakeholders (industry teams, agencies, and societies) make a concerted investment (potentially loss-making initially) to increase the relevance of publication professionals in the region now? Or should they wait until there is a critical mass of publication professionals in the region to support sustainable efforts?

I personally feel it should be the former, but I acknowledge the challenges with such an approach. Until then, there is a need to focus on grassroots initiatives to bring the publication professional community together and facilitate knowledge sharing. I know of such efforts in Australia, New Zealand, China, and Singapore, but these initiatives remain largely contained within each of those countries. The ISMPP Asia Pacific Education Committee has been working hard to develop and deliver regionally-relevant content, but the committee’s current capacity only allows for the roll out of webinars on a quarterly basis.

The region needs a platform that will enable experience sharing and interaction across countries (and languages), and professional societies will need to consider engagement and advocacy with regional/local publishers and journals to support a two-pronged approach to establishing the value of publication professionals.

As the value of real-world evidence continues to be recognised by health regulators, we should also ensure that publication professionals are leading the conversations on best practices for the publication of such data. This will be the game changer for the relevance of publication professionals in the region (and in other countries which may not be involved in clinical trials).

Until then, the challenge remains with publication professionals across the region to continue to drive education and awareness of good publication practice by demonstrating the value of well-developed publications and their dissemination to the relevant stakeholders.”

“As the value of real-world evidence continues to be recognised by health regulators, we should also ensure that publication professionals are leading the conversations on best practices for the publication of such data.”

What about other stakeholders involved in biomedical publishing for example journal publishers, funding institutions, and medical societies? What other initiatives would you like to see them implement to facilitate ethical and transparent regional publication practices?

“It is critical that the stakeholders listed recognise the value of ethical and transparent regional publication practices, so that authors will be more inclined to also adopt such practices. At the end of the day, we need authors to realise that good publication practice will help to improve the quality and acceptance of their publications. Only then will we see a significant shift in attitudes towards the relevance of publication professionals in the region.”

Jonathan can be contacted via LinkedIn.

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The expertise of patients and the additional insights that they can bring to medical publications is increasingly being recognised, with the role of patients and patient advocacy groups among the updates included in the Good Publication Practice (GPP) 2022 guidelines. Following her participation at the 2023 International Society for Medical Publication Professionals (ISMPP) EU meeting, The Publication Plan spoke with Catherine Skobe, Publications Innovative Solutions Lead at Pfizer, to get her thoughts on how to increase engagement with patients throughout the publication process and on other areas for innovation in medical communications.

You’ve been involved in a range of initiatives surrounding patient involvement and the broader theme of inclusivity in medical publications. Could you start by sharing a little about your background and how you came to be interested and involved in these aspects of medical publishing?

I’d like to start by thanking The Publication Plan for the invitation to share my experiences in our field of scientific publications. I began my career in a hospital lab with the patient at the forefront of my work. Over the 20 years I’ve been working in scientific publications, the patient has always been top-of-mind, but how that intersection occurs has evolved. Layering in my experience in public health is where my pursuit in inclusivity stems from, relating to both scientific communications and to who can and who should be involved. Bringing in voices from those who are impacted by a disease is vital to understanding their needs, fulfilling those needs, and delivering well-researched information that enables them, their caregivers, and their healthcare providers to make more informed decisions.

“Bringing in voices from those who are impacted by a disease … is vital to delivering well-researched information.”

At the ISMPP EU 2023 meeting, you talked about Pfizer’s Patient Collaborative Board and its purpose to engage patients as collaborators and partners in medical publishing. Could you tell us how the idea for the board came about and how it builds on Pfizer’s existing approach to patient engagement?

As we began exploring the development of plain language summaries (PLS), I felt it was important that we hear from an audience (eg, patients/patient advocates) we intended to target to fully understand their needs. In 2020, we began with outreach to Pfizer’s in-house Patient Advocacy team to identify patient advocates for an Advisory Board meeting. We also received recommendations from identified Advisory Board attendees. It was important to us to have representation across various therapy areas as well as geography, gender, and ethnicity. During this initial Advisory Board meeting, we discussed the end-to-end publication process and learned a lot about their preferences related to publications. As part of the post-meeting survey, we discovered the attendees found the meeting as rewarding as we did. At that point, we decided to establish an ongoing board to continue the conversation. Changing the name of the board to Collaborative Board was a critical move to ensure all members are equally accountable for deliverables.

“It was important to us to have representation across various therapy areas as well as geography, gender, and ethnicity.”

What’s been the response to the board so far, both from internal stakeholders at Pfizer and from external collaborators including the patients and clinicians with whom you work? What have been the most notable impacts since setting up the board?

Our Collaborative Board is comprised of patient advocates who are eager to share their expertise and provide guidance on what resonates with their communities. To date, the members of the Collaborative Board have helped develop our guidance and resource materials for working with patient authors. In addition, they have shared their voices in our effort to increase open access publishing by participating in webinars and producing video bytes that encourage our internal authors to strongly consider journals that offer open access options. Their involvement and leadership lend credibility to our initiatives with a patient-centric focus.

During ISMPP EU, you mentioned having a 3-year plan for the future development of the board. How do you see its scope evolving? Where are the opportunities to increase patient involvement in medical publications and what are the barriers preventing it – whether based on your own experience or considering the wider medical publishing landscape?

We spent the latter part of 2022 and early 2023 developing the rules of engagement, creating a mission statement, defining our purpose, and preparing a multi-year plan. There is still much progress to be made in scientific publications as far as education for both pharma companies engaging with patients and patients who want to be involved in the end-to-end process. Raising awareness, internal and external to Pfizer, is an important first step in imparting how important it is to engage patients in the process. We also need to understand the formats that resonate with patients, where they go to get their information (ie, discoverability), and which journals and congresses are patient oriented.

A key barrier is the need for peer reviewed PLS and a journal ‘home’ for them. There is a level of trust that comes with both that’s not currently as widespread as it needs to be. Involving patients as authors and as peer reviewers represents a move away from convention but is clearly an opportunity to effect positive  change. By tapping into patient advocacy organizations and combined with proper training, journal publishers could transform their existing models and provide a trusted resource for all seeking information. Ultimately, this effort could improve health literacy, which, in turn, could impact patient outcomes.

“Ultimately, [involving patients as authors and peer reviewers] could improve health literacy, which, in turn, could impact patient outcomes.”

More generally, it seems like we’re seeing more consistency within recent industry guidance and recommendations and journal editorial policies regarding when and how patients should be involved in medical publishing, with the GPP 2022 update as an example. Do you think that’s the case? Are there areas where the guidance could be clearer or more consistent?

GPP 2022 provided an excellent foundation for patient involvement in medical publishing. It was exciting to finally see guidance written that includes this audience, particularly as they are mentioned in the Principles to Support Inclusivity section. Engaging patients at the outset through Steering Committees and Working Groups sets them up to ensure International Committee of Medical Journal Editors (ICMJE) authorship criteria are being met. GPP 2022 gives many great examples of how patients and patient advocates can be involved in publications. Acknowledging that patients/patient advocates can provide a unique perspective and meaningful insights to enrich the data is a move in the right direction for medical publications. For full disclosure, I was a reviewer of GPP 2022.

“Acknowledging that patients/patient advocates can provide a unique perspective and meaningful insights to enrich the data is a move in the right direction for medical publications.”

Switching tracks slightly, you also spoke at ISMPP EU about a recently developed process at Pfizer to use the independent open access repository, Figshare, as a platform to disseminate peer reviewed PLS for manuscripts. Could you tell our readers a little more about this project? What were the pros and cons of using an independent platform like Figshare compared to a company-hosted platform?

We began exploring use cases for Figshare a few years back in 2017–18. It was our work in PLS that became the justification for creating the Pfizer Figshare platform. As we began to develop PLS in tandem with manuscripts, we discovered not all journals have the ability to host PLS on their platforms. Figshare became the solution we decided to pursue. Due to its flexibility, we are also able to provide a repository for supplemental journal materials, enhanced publication content, and eventually a home for Green open access articles. One of the best features of Figshare is its ability to capture metrics. As of early April 2023, we’ve reached close to 10,000 views. However, discoverability of this information remains a hurdle. The Digital Object Identifiers (DOIs) from the Figshare site are shared with the journal to direct readers to the additional content on Figshare, but that is the extent to which the content is disseminated.

We didn’t pursue a company-hosted platform because Figshare already existed and met our needs. This allowed us to quickly implement our idea without the need to build a site. Developing our own site wasn’t on our radar when the need arose.

GPP 2022 contains advice on industry use of social media platforms, and in the UK we recently saw The Prescription Medicines Code of Practice Authority (PMCPA) launch its guidance on social media use for pharmaceutical companies. Do you think there’s a need for similar industry guidance on the use of independently hosted repositories and similar online platforms to enable pharmaceutical companies to use them as a means of data dissemination?

Industry guidance related to social media use, specifically related to publication content, would be extremely useful. We know there is a lot of scientific conversation being held on social media platforms. Being able to share scientific information accurately, in a safe, dare I say regulated manner, could help combat some of the misinformation that is being propagated on social media. In 2017, Sara Rouhi (now with PLOS) and I co-founded ISMPP’s Social Media and Web-based Metrics Working Group. We’ve been waiting since then for guidance on how to safely communicate on social media. Social media platforms remain a bit of a ‘Wild West’, and I believe there’s a need to apply some rigor to at least some areas of conversation when led by certain users.

“Industry guidance related to social media use, specifically related to publication content, would be extremely useful.”

Finally, and thinking more generally about innovation in the medical communications and publishing industry, of the projects that you’ve been involved in, which have you found the most rewarding, whether in terms of their impact or perhaps taking a creative or alternative approach? Are there further opportunities for innovation in patient engagement and involvement or in other aspects of medical communications?

What a fantastic question. The most rewarding project I’ve led was the design and build of our publications management system called Aurora. It was a multi-year project that encouraged blue sky thinking. Aurora launched just a year ago and we continue to evolve her functionality at an unprecedented pace. The ideas on our roadmap could carry us out several years to get to what we ultimately want to have in our publications ecosystem. One of the most compelling features to me is the inclusion of alternative metric data to help us understand how the public is engaging with our research at an article and a journal level specific to Pfizer’s performance. Monitoring engagement is intended to provide a feedback loop to the publication teams to inform them of gaps and successes in communication. Ultimately, we can use these data to make better informed target journal selections for future publications, with a goal of driving down timelines and getting our data into the hands of healthcare professionals and patients faster.

Specific to patient engagement, we will continue to work with our Collaborative Board to understand their needs, measure our performance in open access publishing and patient authorship where patients are impacted, and drive future growth. In addition to PLS, involving patients in enhanced publication content formats is an area we should be exploring. To meet their needs and to improve health literacy, we need to consider providing information in other formats beyond the print publication. Above all, it is important that we engage patients in this dialogue to innovate in meaningful ways.

“In addition to PLS, involving patients in enhanced publication content formats is an area we should be exploring.”

Catherine Skobe, MPH, MT(ASCP), is Publications Innovative Solutions Lead at Pfizer and can be contacted at catherine.skobe@pfizer.com or via LinkedIn. The views expressed here are those of the interviewee and do not necessarily reflect those of their employer.

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Many of us will be familiar with the concept of plagiarised text as a form of misconduct within scientific literature, but perhaps a lesser-known problem, and one which most of us would find much harder to spot, is the publication of manipulated images. Elisabeth Bik is a science integrity consultant who has been described as a super-spotter or image sleuth due to her unique talent for identifying scientific photos that have been tampered with. Elisabeth strives to tackle the issue of scientific misconduct and has a blog dedicated to the topic of science integrity. To date, her scientific detective skills have led to 951 retractions, 122 expressions of concern, and 956 corrections. The Publication Plan spoke to Elisabeth to find out more about her work.

Could you tell us how and why you became involved in investigating fraudulent scientific work and how you discovered your talent for spotting duplicated/manipulated images?

“In 2013 I heard about plagiarism so I took a sentence that I had written and put in into Google Scholar to see if anybody had used my text. I had not expected any results, but by chance the sentence that I had picked randomly, had been stolen by somebody else, so I found a paper that had plagiarised my text, and that of many others. I subsequently kept on finding more and more papers that had plagiarised other people’s work. I worked on that for about a year whilst I was working full-time at Stanford, so it was a kind of weekend project. Then in around 2014 I came across a PhD thesis, not one that had stolen my work but one that had plagiarized text, and one that also contained images – western blots. A couple of the figures had panels that had been reused, so the same panel had been used to represent different experiments. The panel had a very distinctive shape and so I realised that I had some talent for spotting these things, and started searching for other papers with similar image issues.”

What do you look for when analysing images, and what are the most common issues you encounter?

“I look for photos specifically because they contain a lot of information, much more than a line graph”.

“I look for photos specifically because they contain a lot of information, much more than a line graph. A line graph could be duplicated but it is very hard to remember, as it’s just a line. Whereas there are features in photos that you can remember at least for a short period, so I compare photos within scientific papers. Because I mainly focus on photos of blots or gels, or microscopy photos of tissues and cells, those are typically the types of images where I find issues, but sometimes I work on photos of plants or mice, visible objects that don’t require a microscope. Occasionally I will find a plot that has been duplicated but as I said plots are hard to find so I don’t focus on those. I look for duplications. There are three main duplication problems: two panels that have been duplicated; two panels that have been duplicated and shifted so that they sort of overlap; and duplication of elements within a photo, for example a group of cells might be visible multiple times. Occasionally I will also find evidence suggestive of tampering with a photo, for example you might see a different background around one particular band in a gel, which indicates that it did not originate from that photo. This example is not a duplication but a sign of potential tampering – that parts of the photo came from somewhere else.”

How common and widespread is the problem of duplicated/manipulated images within the scientific literature and what are the potential consequences of such images going unidentified?

“Duplications are found in around 4% of papers that contain at least one photo. This finding is based on a systematic search I performed for papers that contain the term ‘western blot’ to enrich for papers with molecular biology photos or other figures. In the resulting set of papers, I scanned 20,000, and I found around 800 to contain duplications, so that’s 4% of papers. Those contained one of the three types of duplication I listed, which could result from an honest error or could have been intentionally duplicated with an intention to mislead the reader. The first case, an honest error in a photo, is usually not a big problem. In my opinion it should be corrected, but we all make errors in papers, and so that’s the least concerning. But when images are duplicated with overlaps, or are rotated or stretched, or contain duplicated elements within the same photo, that’s clearly a manipulation of the data. To me those are visible signs of manipulation which cast doubt over all the data in that paper, because if one image has been potentially tampered with or manipulated then so might have other types of data, which are much harder to catch. For example, you cannot really see if values in a table have been fabricated or manipulated so it makes the whole paper less reliable and maybe also other works by those same authors. In some cases, images are manipulated to make the data look better. If a photo contains duplicated elements, then you can’t even be sure that the experiment happened and what the results were. Duplications within the same photo are very suggestive of an intention to mislead and that the results were not obtained as they have been presented. Such fraud in my opinion goes against everything that science should be – science should be about finding the truth and fraud is the opposite of that.”

“Fraud in my opinion goes against everything that science should be – science should be about finding the truth and fraud is the opposite of that.”

What proportion of questionable images do you think could result from honest error and how many are likely to be deliberate acts of misconduct?

“In the study I referred to previously, where I found 800 of 20,000 papers to contain duplicated figures, we estimated that about half of the duplications were deliberate. It is sometimes difficult to know whether a duplication is deliberate in an individual paper, but because we had 800, that was our best guess. It was based on there being roughly an equal distribution of papers over the three duplication categories, so 30% in each category. Since overlapping images could result from honest error, we estimated that about half of the 800 papers had deliberately duplicated or manipulated photos, so 2% of papers overall. Of course the real percentage of manipulation might be much higher because at least photos leave traces if you manipulate them, but as I said, manipulation in other types of data, such as tables or line graphs is much harder to detect so the real percentage of papers with misconduct might be much higher than 2%.”

What systems do journals have in place, if any, to identify problematic images before publication and what are the limitations of these systems?

“Some journals scan all incoming papers for image duplications and others have traditionally hired people like me who can spot these duplications, to scan all their accepted papers for image problems. This might only take a couple of minutes per paper so it’s really not a huge time investment if you know what to look for. After I raised my concerns about 4% of papers having image problems, some other journals upped their game and have hired people to look for these things. This is still mainly being done I believe by humans, but there is now software on the market that is being tested by some publishers to screen all incoming manuscripts. The software will search for duplications but can also search for duplicated elements of photos against a database of many papers, so it’s not just screening within a paper or across two papers or so, but it is working with a database to potentially find many more examples of duplications. I believe one of the software packages that is being tested is Proofig. I have never worked with this software so I don’t know exactly what it does or how good it is, but I would love to test it. Although there have been situations where an editor has informed me that Proofig didn’t find any evidence of a duplication or any evidence of tampering with an image in which I can clearly see a problem. So I think there is a danger if an editor doesn’t really know how to use the software or just blindly relies on the software’s verdict.”

What kind of response do you tend to get from journal editors when you report a potential issue in one of the papers they have published? Your work has resulted in numerous retractions and corrections – is that a common result when you notify a journal of an issue?

“In the past no response was common – I would just not hear anything. Nowadays I specifically write in my email that I keep track of which journals respond to my message, so I usually receive a notification or acknowledgement of receipt or something like that, but then very often I still hear nothing. I reported that initial set of 800 papers in which I found problems to the journals in roughly 2015, and kept track of what happened – two-thirds of those papers have not been retracted after 5 years, some are still being retracted so the number is steadily going down, but around 60% of papers have not been addressed. For the more current papers that I’ve reported, that number is slightly better with half not being addressed after waiting a year or two, but the majority are still not addressed. I get an acknowledgement of receipt but then it seems that nothing happens. When an issue is addressed, the two most common outcomes are a correction or a retraction, which each account for roughly half of cases. There is also a tool called expression of concern, which is very rarely used but I feel should be used more because it provides a very fast way for an editor to flag that they have been alerted to a big problem with the paper and are investigating it, so readers know to proceed with caution if they read that paper. As mentioned, corrections and retractions are the most common outcomes but they are only used in about 40 to 50% of cases – for the majority there is still no outcome after waiting a couple of years.

“Corrections and retractions are the most common outcomes but they are only used in about 40 to 50% of cases – for the majority there is still no outcome after waiting a couple of years.”

But I do feel that the situation is improving, maybe my work has finally earnt some acknowledgement that I’m signalling for positive reasons, not out of malice. In the past I have felt I’ve been ignored a little bit more and I go to social media sometimes too to vent about the lack of response from journals, which I feel has helped so the numbers are getting better but I feel that journals can still do a much better job.”

How important do you think websites such as PubPeer, Retraction Watch and your own blog, Science Integrity Digest, are in creating transparency and raising awareness of possible flawed research? Does the creation of such sites indicate an increasing problem or a greater awareness of the need to check the integrity of science?

“I don’t want to talk about my own blog too much, but I do feel that PubPeer and Retraction Watch have played a huge role in openness about problems in papers. There is no other good website where you can report problems. You may try writing privately to a journal, or sometimes there are comments sections in journals, but very often these comments disappear after a while or they never come out of moderation. I feel PubPeer does a really good job in alerting people that there might be a problem with a paper and it’s the only platform that I know of that we can use. Retraction Watch offers a glimpse of what happens once a paper gets retracted because they provide the background to a retraction. In many cases a retraction notice is very vague, simply stating that the authors or editors decided to retract the paper because of a problem without indicating what the problem was, which is not fair for the reader because parts of the paper may still be good. We want to know why the paper was retracted and what the specific problem was. Retraction Watch go into a little bit more detail, they interview people – the scientists, the authors, the editors – and ask them for their side of the story. Sometimes you learn that a retraction was actually a very good thing because an author found, for example a big problem with their paper due to a mistake in a formula, so they did the right thing in retracting their own paper. To hear people talk about why they retracted a paper is very useful and gives you a lot more information. I feel both Retraction Watch and PubPeer create transparency as a lot of these cases are otherwise hidden by the journals or institutions.

As to whether it is an increasing problem, I do believe it is for several reasons. First, papers are getting more and more complex, which provides more opportunities to fake data. Digital photography also means it is much easier to digitally alter a photo than it used to be – when I did my PhD you would still bring your gel to the photographer, there was no digital photography and subsequent Photoshopping.  Another reason is the increasing pressure to publish. Certain countries have really increased their pressure to publish and made it mandatory to publish for example, a paper when you finish your Master’s degree or to publish multiple papers when you finish your PhD, or in medical school you need to publish a paper to get a promotion. China in particular has issued a lot of these mandatory publication demands. In some cases they are impossible to fulfil as people do not have the time to do the research, but of course they still want to get a promotion or a position at a hospital so they might just buy a paper. Therefore, there is this whole growing market of papermills, which are companies that mass produce papers. There are different models but they basically sell fake papers to authors who need them, which was not a problem that existed 20 years ago. If you look at papers from 30 years ago I’m sure there was fraud but those papers usually only contained one figure and one table, so there were fewer opportunities to commit fraud compared with papers today that have 6 to 8 figures and additional supplementary figures. Although I feel that this is an increasing problem, I believe that there is also a greater awareness of the issue”

What more could be done to improve research integrity within the scientific literature? How do you think the research integrity landscape will have changed in 5 years?

“I hope there is more emphasis on reproducibility in the future because I feel reproducibility is the only way for us to know that an experiment has really been performed and yielded the reported results.”

“I hope there is more emphasis on reproducibility in the future because I feel reproducibility is the only way for us to know that an experiment has really been performed and yielded the reported results. I hope we have less emphasis on output – measuring a scientist’s output by measuring numbers of papers or impact factor – to remove some of that pressure and instead reward reproducibility. Reproducing a study may not be novel and of course there is not a lot of funding for it, but I feel it gives so much more validity to a study than trying to do something new. Pre-registration of clinical trials is a wonderful thing as it requires people to publish their results even if they are negative, which I feel might result in less cheating. I’m also very worried about artificial intelligence (AI) and its potential to create fake papers and images. We’ve seen several examples of what technology can do right now, if you think about dinosaurs in movies, they look more and more real every year, so I think in the next 5 years AI is going to be a huge problem for scientific publishing, because it might generate fake photos, data and text. Distinguishing what is real and what is fake, which may be impossible in 5 years from now, will be a problem for journalists too. We need to think about how we can prove that images, photos or other data are real. The obvious errors that we currently use to determine that a paper is probably faked can be overcome by a very smart fraudster – they can make their images look very realistic and AI is going to help them tremendously, so I’m very worried about that. I’m not quite sure if we can safeguard the integrity of science with the ever-increasing amount of pressure that we put on scientists and the advantages that digital photography and AI can offer fraudsters and so I’m a bit pessimistic there, but I hope we have more funding to look into solutions, technical solutions for that. Some of that is solvable – we can maybe look at original images, and ways of proving that they really came from a microscope for example, and were not generated by AI. I’m not quite sure how, that goes beyond my technical comprehension of the issue, but there are hopefully ways to solve that.”

Elisabeth Bik is a science integrity consultant. You can contact Elisabeth via LinkedIn.

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The key role that patient advocates can play in medical research is widely recognised, if sometimes underutilised. Beyond participating in clinical trials, patient advocates have an important part to play in engaging and educating other patients, as well as amplifying the patient voice in the medical research sphere. After her appearance on an International Society for Medical Publication Professionals (ISMPP) Annual Meeting 2022 panel discussing the democratisation of medical research, The Publication Plan spoke with Dakota Fisher-Vance, Global Patient Advocacy Associate Director at BioCryst Pharmaceuticals, to talk about her experience as a patient with familial adenomatous polyposis (FAP) and as a professional patient advocate.

First of all, could you tell our readers your story and how you became involved with patient advocacy?

“I am a patient advocate in my personal life as well as in my professional life. In 2011, just after I had graduated from college and was planning to go to medical school, I was diagnosed with the rare, hereditary cancer syndrome, FAP. The diagnosis shifted my perspective as I didn’t want to study the functions of the colon when I was about to lose mine. As I encountered healthcare providers, I saw a lot of deficiencies on the other side of the stethoscope, particularly related to patient education and advocacy. I wondered whether I could effect more immediate change in these areas without going to medical school.

“I saw a lot of deficiencies on the other side of the stethoscope, particularly related to patient education and advocacy.”

I was initially hesitant to get involved as I didn’t want my career to be defined by my disease, but when I was later diagnosed with a desmoid tumour, which is related to FAP, I realised it was something I was going to need to learn to live with. I started to get involved, meeting other people with FAP and created the first YouTube channel for people with my disease. I thought it was important for patients to have a friendly face providing relevant information about FAP, particularly as this wasn’t always so easy to find due to an unfortunate slang meaning of the acronym. The YouTube channel was discovered by a health technology start-up that was creating online communities for specific rare diseases and their model disease just happened to be FAP. They ended up offering me a job and, ultimately, that culminated in my becoming involved in patient advocacy professionally.”

The involvement of patients, advocates and caregivers (PACs) in the rare disease arena is often “unrecognised, unexpected and/or unappreciated” according to your Future Rare Diseases publication. Could you describe the ways in which PACs provide invaluable support to the rare disease arena in particular?

“I always say patient advocacy is invaluable no matter what disease state you’re working in, but I think this is particularly true for rare diseases, where there’s a smaller group of patients. If you’re looking at a disease that only affects 500 people in the world, you really need to work with the patient advocacy community to help elevate PAC voices. Otherwise, how do you know you’re doing what’s best for those patients? There are myriad ways in which patient advocacy is invaluable in rare diseases, as we discuss in the article. The rarer the disease, the more informed and engaged the individual patient is going to be, by necessity, since you’re less likely to have a lot of medical professionals and research in that area.”

“Patient advocacy is invaluable no matter what disease state you’re working in, but I think [in rare diseases]…you really need to work with the patient advocacy community to help elevate PAC voices.”

Your own experience with FAP has perhaps driven your passion for greater involvement of PACs in rare diseases, but can you explain how greater PAC involvement would benefit all stakeholders across diseases and conditions?

“We can step back and ask ourselves a question that I don’t think a lot of stakeholders in healthcare ask: ‘What is healthcare without the patient?’ There could be a terrible disease out there, but if there isn’t a single person with or susceptible to the disease, how are you possibly going to find a cure? I also like to think that bench researchers who may be working on something that is a long way from reaching patients are motivated by the fact that, ultimately, their work could translate into a benefit for patients, not by doing cool science or getting their research published in a high impact factor journal. This also applies to physicians: I like to think that they’re working in these areas because they want to work with, and help, patients. So, no matter what the disease state is, patients and the advocacy groups that have formed to elevate their voices can guide all these stakeholders along the right path.

“What is healthcare without the patient?”

In your article you call for patient-centricity to “become a reality rather than just the latest fashionable catchphrase.” Given their key role in research, trials, strategy, and education, what should pharmaceutical companies be doing in terms of patient involvement?

“This is a big question. Over the years, we’ve started to see pharmaceutical companies shifting their perspectives and becoming more interested in the roles patients play. Initially, I think they saw the importance of payers and then healthcare providers as key stakeholders, and now I think they’re starting to understand that patients are the consumers and that they really matter too – they’re an equally important stakeholder. Once they have that perspective shift, pharmaceutical companies need to constantly monitor their patient community involvement to make sure it’s not superficial, even for those pharmaceutical companies that have high impact activities and high levels of engagement with patient advocacy groups. It is important companies make sure that the belief that patients are equally valuable stakeholders trickles down into functions throughout the whole company. This aspect can      get lost as companies grow, so pharmaceutical companies need to ensure that new people coming in share this value and know how to implement it in their work.”

“[Pharmaceutical companies are] starting to understand that patients are the consumers and that they really matter too – they’re an equally important stakeholder.”

Following your experience creating a YouTube channel to raise awareness about your disease, do you see the role of digital and social media expanding as platforms for patient advocacy? Could pharmaceutical companies do more to engage with patients via these platforms, assuming appropriate regulations are in place?

“It’s a tricky and relevant question. With the YouTube channel that spawned my career in patient advocacy, I was involved in social media from the creator side, and then I have worked for a company that was engaged with digital opinion leaders in different rare disease states. I have seen companies begin to realise that it’s not just non-profits and advocacy groups using social media; there are individuals posting on Instagram and TikTok, and these people are important in the advocacy landscape too. In rare diseases, you may not have an advocacy group, but there may be someone running a blog, so people engaging via these platforms are very important voices in the community. The evolution we’ve seen – from patients sharing their experiences via blogs and YouTube in 2011 to TikTok and Instagram now – is only going to continue to change. In my current position, I take a very conservative approach with social media. As a company, you don’t want to be perceived as interfering with these patient communities or trying to share unsolicited information. We know these communities are important, but it is challenging to know how to engage in a compliant manner. Personally, I would love to see more guidance on how to recognise these PAC voices and make sure they’re heard, to help cultivate these communities.”

“As a company, you don’t want to be perceived as interfering with these patient communities or trying to share unsolicited information…I would love to see more guidance on how to recognise these PAC voices and make sure they’re heard, to help cultivate these communities.”

Which of the projects you’ve been involved with have you found the most rewarding? Are these the same activities that have had the greatest impact on the wider community of patients that you advocate for?

“From a personal standpoint, one of the best things I’ve ever participated in as a patient was a young adult cancer video series. I’m very passionate about building community and providing educational resources for young adults who have or have had cancer. One of the biggest challenges I had when I was diagnosed was trying to figure out how to talk about that experience with my peers. As a young adult, your only encounter with a disease may be through your grandparents, then suddenly, as a twentysomething, you have to start talking about cancer, chemotherapy and all of these scary, foreign things. It can be quite challenging. I had an opportunity to participate in a video series that was specifically about how to talk to your friends about a cancer diagnosis. It was created for and by young adults with cancer: the director, the writer, and the whole cast had cancer or were a care partner of someone who had cancer as a young adult. I knew it was the number one resource that I wished had existed when I was diagnosed, so it was really quite meaningful and one of the coolest, most rewarding things I’ve participated in.

I have also worked on various patient advocacy projects professionally that have had a lot of impact and feel that psychosocial and educational support is just as needed as advocating for research funds and engagement. Improving patient involvement in research is obviously the most important thing, as developments from research activities are what, hopefully, are going to extend lifetimes. But the outcomes of that research may not reach the patients who are living with the disease today, whereas educational and psychosocial support has an immediate impact on the patient community.”

Medical journals are increasingly encouraging the inclusion of plain language summaries (PLS) in publications, which is an important step forward in terms of patient advocacy. How else can publishers help you in your quest for patient-centricity?

“I think there needs to be more education on the industry and academic side, as well as on the patient and patient community side, to understand how patients can get involved in medical publications.”

“I’m really glad to see the movement towards including PLS, but it’s still a very confusing topic, speaking from a pharmaceutical company perspective. I’m not overly involved in our medical publications, but I’m certainly interested, and the ISMPP meeting motivated me to learn more about PLS, among other aspects of medical publications processes. I think there needs to be more education on the industry and academic side, as well as on the patient and patient community side, to understand how patients can get involved in medical publications. PLS might be the initial step, but we need to look more broadly at whether we can have patients as authors on other publications and educate academia and industry on what that looks like. We’re currently asking ourselves basic questions, like what is a PLS, when is one needed, when would patients most benefit from one, what do patients value most, and how does that differ for different disease communities? We’re struggling to answer some of those questions, and it would be really beneficial if publishers could share data they may have already gathered about PLS uptake and value to help us navigate these unknowns.

Likewise, you need to educate the patient community about PLS. One of the questions I got asked at the ISMPP meeting was how many patient advocacy groups were pushing the companies they’re working with to do PLS: from my limited research, I don’t think there’s a huge voice calling for it from the advocacy community. Therefore, more education would be beneficial for patient advocacy groups to leverage making PLS more common.”

The recently published Good Publication Practice (GPP) guidelines: 2022 update include some important updates with regards to patient inclusion (eg recommendations to include patients and patient advocates in publication steering committees and working groups, and as publication contributors, authors and reviewers, as appropriate). How can we make it easier for patients to be involved in publications? What barriers need to be overcome for patients to be key stakeholders in publications?

“I think the biggest barrier to be overcome is shifting the perspective of the academic or pharmaceutical stakeholders who may be leading the publication process to get them to see involving patients in publications as a valuable and worthwhile investment. Equally, there’s a perspective shift required from the patient community to allow them to realise that they have something valuable to add. For example, even though patients may not be writing every sentence of a publication, they can still help interpret the data, or help with the survey instrument used to collect the data. The other challenge is to build the credibility of the patient as a stakeholder. If everyone involved can invest in improving the scientific literacy of the patient community, that’s going to help with building credibility and that perspective shift, but also equip the patient community to be better authors and stewards of information. This all comes down to fostering information sharing, encouraging patients’ curiosity by sharing the data, and getting the patient community engaged with information relating to their disease. Ultimately this benefits pharmaceutical companies, as the more the patient community engages with publications and scientific information, the better authors and self-advocates they’re going to be.”

“If everyone involved can invest in improving the scientific literacy of the patient community, that’s going to help… equip the patient community to be better authors.”

Finally, looking ahead – what do you think the future holds for patient advocacy? What big change would you really like to see?

“I’d love to see a patient advocacy function incorporated into every pharmaceutical company, or at least processes to make sure companies are considering the patient voice in everything they do, and ultimately considering the patient community to be equal to every other stakeholder. I’d love to see that recognised in terms of how we compensate the patient community for their engagement. Usually, patients are compensated at a flat hourly rate, which isn’t the approach we’d take with other key opinion leaders. It’s not just companies that need to recognise the patient community equally: patient advocacy groups can also do more, like having both a scientific and patient advisory board. This applies to patients too: as a patient, you need to know your value and the risks if you’re not actively engaged with your healthcare team. Ultimately, it’s about knowing that without patient engagement and participation, scientific advancement in your disease state may stagnate. Across the spectrum, I think everyone involved needs to recognise the value of the patient community as being equal to that of other stakeholders in the space, and I don’t think we’re quite there yet.

“Ultimately, it’s about knowing that without patient engagement and participation, scientific advancement in your disease state may stagnate.”

When I was approached to talk at the ISMPP meeting about medical publications, it wasn’t necessarily an area I think about day to day or somewhere where I felt I could add value to the conversation, but being at ISMPP, I realised we’re still so early in the move towards involving patients in the publication process and that just being part of the conversation was tremendously valuable.”

Dakota Fisher-Vance is the Co-Founder of Young Adult Cancer Connection, a professional motivational speaker, and is Global Patient Advocacy Associate Director at BioCryst Pharmaceuticals. You can contact Dakota at dfishervance@yacancerconnection.org or on LinkedIn.

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Many of those working within the medical communications industry will be familiar with the Good Publication Practice (GPP) guidelines, which were recently updated with the publication of GPP 2022. The guidelines provide recommendations on how to follow ethical and transparent practices when publishing company-sponsored biomedical research. GPP 2022 is the fourth version of the guidelines, which were previously updated in 2015 with the release of GPP3. The Publication Plan spoke to Lisa DeTora, Associate Professor at Hofstra University and lead author of GPP 2022, to find out how the guidelines were developed and to gain her insights on some of the new topics covered.

Could you explain why the time was right to update the guidelines and briefly summarise the key topics introduced in the new version?

“Although I was not part of the decision-making process that determined a new GPP iteration was needed, my understanding is that several new areas were identified that required some guidance—notably enhanced content and patient involvement in publications.

We concentrated on stating the goals of GPP in positive terms. Unlike the GPP3 team, who had to contend with negative coverage of publication planning in the press, we were able to define good practice without having to address negative accusations or practices. As such, GPP3 indirectly reflects on some media preoccupations with bad practices, including ghostwriting, and how to prevent them, whereas our team was able to concentrate on defining what we as a profession already do well and to present additional best practices that have emerged since 2015.

The scope of GPP 2022 expanded beyond clinical trial publications to cover all scientific areas. We moved away from mainly considering Consolidated Standards of Reporting Trials (CONSORT)-specific papers and acknowledge that the International Committee of Medical Journal Editors (ICMJE) authorship criteria are not universally used, even though they are an appropriate default if no other authorship guidelines are specified.

We broke down the various processes in publication planning in a supplement that walks the reader through steering committees, publication planning, authorship determination, publication working groups, and the publication process. In each of these areas, we included new information as needed on working with patients, working in alliances, social media, enhanced content, and plain language summaries (PLS). These sections are intended to be usable for day-to-day work, for training teams, and for orienting newcomers to the profession.

“We included new information as needed on working with patients, working in alliances, social media, enhanced content, and plain language summaries.”

We also added information about the leadership potential of publication professionals in developing policies and standard operating procedures (SOPs), and training teams.

Inclusivity was also an important new theme: we considered this in terms of demographic criteria, job roles, patients, and including investigators from various regions on author bylines.”

GPP 2022 was developed with input from pharma, medical communication agencies, journal editors, publishers, and academics, and underwent substantial review with over 150 invited expert and International Society for Medical Publication Professionals (ISMPP) member reviewers providing feedback. Could you briefly describe the development process?

“The original vision for this GPP iteration was to update GPP3 and then to add any new sections that might be needed. However, as the steering committee members began to develop the new content and updates, it became clear that we could produce a much more usable document. I was nominated to produce the full draft in part because I had some ideas about how I would organise what is now the supplement, and how those sections could be used for training and to introduce practices to investigators, students, and others. It was a little daunting because I had not envisioned being asked to take on a decision-making role for this work. Luckily, the steering committee was very supportive and positive.

In terms of the process, the steering committee began by identifying GPP3 content that required an update and new content that needed to be added. We reviewed all the content together, then I organised a new draft. The steering committee commented, and a consolidated document was then shared with a panel of 38 experts selected by the steering committee in consultation with ISMPP’s leadership. We consulted with ISMPP because we wanted to include expert reviewers who lead publications teams at pharmaceutical companies.

Fiona Plunkett (Articulate Science), Dan Bridges (Inizio Medical), and I then reviewed the 38 sets of expert comments. I consolidated the comments that we felt were feasible to include, then the steering committee commented, and the resulting document was sent for a review by ISMPP volunteers, who had been identified through an open call. Volunteer reviewers were asked to solicit feedback within their groups or companies and return consolidated comments via a portal set up by ISMPP. The steering committee members divided up the comments for preliminary review, but I read all of the comments and Dikran Toroser (Merck) read most of them as well, before I consolidated the document.

We accepted every comment that we could. I felt strongly that we needed to make sure stakeholders felt heard. As expected, though, some of the comments conflicted and then we deferred to the original steering committee views. The majority of the comments that we could not address were highly specific to a particular working setting or were editorial in nature. For instance, there were suggestions about minimum and maximum numbers of authors or steering committee members; the rationale for each of the suggestions was sound in a specific context but didn’t always apply in other scenarios. We also listened to feedback in person at the ISMPP Annual Meeting and in our day-to-day working relationships.

There was only one substantive difference of opinion regarding what to include in GPP 2022, and that was resolved by deferring to regulatory frameworks. In all other cases, we were able to develop text that would accommodate a range of acceptable approaches. For instance, we do recommend steering committees if teams need advice about scientific strategy or journal selection; however, it is not always feasible to have a separate steering committee and publication working group.”

How did you ensure that the guidelines represented balanced views and experiences of a diverse group of stakeholders, and that all voices were heard?

“We tried to keep GPP 2022 as neutral and high-level as possible, and to emphasise the idea that inclusivity should be considered in all areas of publication planning and development. The steering committee itself is diverse and we also solicited feedback from a diverse group of expert stakeholders. In addition, we accepted every comment that was feasible to address from the volunteer review.

One thing to keep in mind about listening to diverse voices is that a high-level document like GPP 2022 is not the correct place to establish what counts as diversity and inclusion in practice for every working setting. All we can do is to indicate that best practice in research and publication includes attention to diversity, equity, and inclusion at all stages. Attention also needs to be paid to inclusivity and diversity during study design, for instance, but that may be outside the remit of many publication teams. We can look to the ICMJE Recommendations for a model: they indicate that author lists should reflect representation from all regions (and countries, if feasible, I believe) in which a study was performed. I personally feel that we all need to keep thinking and continuously evaluate how we are doing in terms of diversity and inclusion and in listening to various stakeholders. We can employ “Lean” or Six Sigma practices that emphasise continuous evaluation, for instance.

Of course, there is more work to be done. It’s impossible in a high-level document like GPP 2022 to fully capture methods for building trust and working relationships with patients and patient advocate groups, or to account for regional representation in multiregional clinical trials or other kinds of studies. It’s also difficult to mandate how and when to include patients, given the wide range of study and publication types we consider. The best we could do for this initial mention of patient participation in GPP is to emphasise that patients should be included as appropriate—for instance in publications of clinical trial results in chronic conditions and/or rare diseases—and as equal partners. Patients should be treated as experts in living with conditions, whose expertise warrants respect, and authorship, if they contribute substantively to a publication. However, patients are autonomous beings and should therefore be included in the decision-making process and allowed to opt in or out of specific roles as they see fit. The idea is to foster inclusivity and not to create additional requirements that might impede publication.

“Patients are autonomous beings and should therefore be included in the decision-making process and allowed to opt in or out of specific roles as they see fit. The idea is to foster inclusivity and not to create additional requirements that might impede publication.”

Another sticky issue is including investigators from various regions on author bylines. There has been a past pattern of not including investigators from certain regions on the main author byline of a publication, but adding names for regional conferences. The current ICMJE Recommendations indicate that the main author byline should reflect all of the regions in which the research was conducted. GPP 2022 supports this position as well: if authorship reflects the full breadth and scope of participation in multiregional clinical trials, then there is no need to manage additions for conferences.”

The guidelines note that patients and patient advocates may author publications or be involved in publication planning. What do you think are the key benefits of patient involvement?

“In my opinion, the key benefit of patient involvement in publications about rare or chronic conditions is that only patients really understand the lived experience of having those conditions. Patients are the only true experts regarding these experiences and are the only group of people who can contextualise scientific outcomes in terms of patient experience. Understanding patient experiences is also vital for anticipating compliance issues, untoward outcomes, or even what kinds of outcome measures could be used to assess certain kinds of adverse effects. Patient input is essential for fully understanding patient reported outcomes, not only in terms of interpretation but also for designing the measures in the first place.

In clinical study settings for acute illnesses or vaccines, patient or participant involvement may still be important and should be strongly considered. It may not be necessary to have a patient on every publication, but patient steering committees may offer important advice to publications teams, review manuscripts, and provide guidance on the best way to represent study findings in plain language. As I said earlier, GPP can’t mandate the exact practice for every situation; however, there should be some mechanism to solicit patient or participant input on relevant publications, even if the patients and participants opt not to engage with the publication process.

Another important benefit to patient involvement in publications is holding the biomedical research community accountable for communicating their findings clearly, accurately, and completely. It is all too easy for researchers to become used to interacting only with other experts, and rely on readers to fill in the blanks of logic or data interpretation. The need to communicate with patients can help experts keep in mind that many different groups of people rely on their research, and to be thorough and complete in presenting analysis and interpretation of results.”

Were any challenges or obstacles identified that may need to be overcome for patients to more frequently author publications?

“In my view there is a difference between including patient voices in the publication process and trying to expand patient authorship of publications. I really think that patients need to be making the decisions about how they would like to be involved in the publication process and whether they would like to expand their presence as authors. For instance, we need to think about the burdens of authorship—which can be difficult and time consuming—and what it’s fair to ask patients to do. We also need to consider what patients want to do. There are potential questions of medical confidentiality to consider, for instance. However, these are my opinions, and the opinions that are truly needed are those of patients who might want to author or provide different kinds of feedback on publications. We should also consider the value of patients as peer reviewers of publications and PLS.

In terms of GPP 2022, we did not delve deeply into these questions because we took the stance that patients should be included as equal stakeholders at all stages of the publication process, where appropriate, which leaves the decision-making to those specific teams and those patients. In general, I believe that it is important that patients take the lead in setting the terms of these discussions. The most important thing to remember, again in my opinion, is that if patients are involved, they should be treated as co-equal partners with investigators and other publication stakeholders.”

GPP 2022 endorses the inclusion of enhanced content with publications, including PLS. Could you explain why PLS are considered so important and briefly outline the key recommendations on when and how they should be developed? 

“Enhanced content utilises different forms of media, often visual media, to make publications more accessible to various expert and nonexpert audiences. For instance, supplemental tables might be included to allow meta-analytical work, or a 1-minute video could explain the key points of a clinical study to help researchers decide whether or not to read a paper in detail. In paediatric trial settings, enhanced content in comic book or infographic form can also be really useful for conveying information. Such visual formats can also be beneficial in settings where literacy is an issue, or if there is a need to communicate with speakers of minoritised languages.

GPP 2022 recommends that a PLS accompany every publication of clinical trial data that follows the CONSORT guidance—which basically means every primary publication. Of course, a PLS might be helpful for every publication, but it is especially critical to communicate clearly about clinical trials of products currently being used in medical practice.

“For me, the most important function of a PLS is that it forces the authoring group to state plainly what they think the main impact of their publication is.”

For me, the most important function of a PLS is that it forces the authoring group to state plainly what they think the main impact of their publication is. It can be easy to fall into ‘expert speak’ and assume that all readers will be able to navigate technical jargon and fill in any gaps in logic. However, PLS have many audiences, from patients to medical students to experts or healthcare professionals who speak English as a foreign language. The PLS format requires a clearer statement of the work’s importance.

There are many ways (and times) to develop a PLS. The simplest PLS is an abstract form that restates the study design and outcomes in plain language. Developing infographics or comics or video can be more expensive and time-consuming. Teams should consider carefully which audiences they are serving and how important it is to convey which information to those audiences. One recommendation I have is to look at recent statements on PLS by publishers and editors. Journal requirements will help guide teams regarding the time needed to develop a PLS to accompany a publication.”

The importance of inclusivity is highlighted in GPP 2022. Could you describe the aspects of inclusivity considered by the guidelines and share some examples of how those working within medical communications might be able to encourage inclusivity in publications?

“GPP 2022 recommends inclusivity of many sorts—from demographic characteristics to job roles, to countries and regions, to patients. One basic recommendation is that diversity, equity, and inclusion must be considered when assembling teams, steering committees, and working groups.

“One basic recommendation is that diversity, equity, and inclusion must be considered when assembling teams, steering committees, and working groups.”

This includes diversity in terms of race, ethnicity, and gender as well as scientific roles. Treating patients as co-equal partners is another form of inclusivity we recommend, as is including investigators from various regions on author bylines. Obviously, the best place to start thinking about inclusivity is at study design stage—but publication professionals should still consult with subject matter experts and data owners to identify diverse teams even if they enter the picture after study design is established.

In general, it’s easy to try to be inclusive but difficult to adjust team culture to accommodate differences and be truly equitable. For instance, including regional investigators may require adjusting timelines and being tolerant of multi-language working situations. I’ve worked on teams where we accepted comments in all languages spoken by the co-authors and then produced the drafts in English. It’s also important to recognise that in some cultures, opinions must be requested more than once. It may also be necessary to adjust meeting times to include partners around the globe. Patients and investigators are also people who have jobs and other responsibilities, which may mean that timelines need some adjustment in order to be truly inclusive.”

The development of GPP 2022 took place during the COVID-19 pandemic. Did any challenges faced by the medical publications community during this time, or changes such as the rise in popularity of preprints, impact any of the recommendations?

“We were somewhat delayed from our initial timeline because many people working within the industry became a lot busier. And those, like me, in academic roles had a lot of added logistical pressures. I asked to include a statement about publication ethics during public health emergencies in GPP 2022, which was received as rather non-controversial by the rest of the authors, given the circumstances. We did have some discussion of preprints, but it was actually quite easy to come to a consensus about our recommendation because we were well aligned around the idea that preprints have a specific function, but should not be used to circumvent the peer review process.”

Were there any topics included in GPP 2022 that proved particularly controversial or difficult to reach consensus on?

“We were quite well aligned at a high level on almost every issue. The logistics or granular details at times are not entirely aligned, but that is a circumstance out of any individual person’s control. It is a strength of the group, in fact, that we are not all working in precisely the same way.

The one thing I’m comfortable saying about any ‘lively debate’ among the team members was that it always seemed to arise out of what turned out to be authentic legal and regulatory differences. In other words, we did not really disagree ultimately, but we were coming together from different positions and/or working within different frameworks. For instance, social media posting doesn’t fall under ‘safe harbour’ protections for industry partners, and caution is warranted when developing a standalone PLS if any information is off-label. This meant that certain ‘common sense’ approaches would not work in all situations. We therefore recommend evaluation of legal and regulatory requirements on an ongoing basis, as well as consulting with legal and other experts.

Another interesting conversation was how to manage situations in which legal or other constraints were not the same for all stakeholders. For instance, compensating investigators to be on a steering committee might be a legally reportable transfer of value, which would not be the case for patients who are not healthcare providers. Similarly, social media posting about publications can have very different implications depending on who is posting and the relationship of the publication to label indications or accepted treatment guidelines. We tried to offer advice that took all of these considerations into account, but individual publications professionals will still have to manage day-to-day situations.”

How have the guidelines been received so far? Have you received any initial feedback as to how they will be incorporated and used?  

“My impression is that they’re being adopted as feasible. There are some changes, and many publication teams still work primarily with clinical trial publications, which means that some of the new information does not apply. We received 0% negative feedback during the reviews, which was very gratifying after putting in so many hours.

A few people have been fairly clear in wanting very specific guidance to be included. One instance is specific limits on the number of steering committee members or authors: these make sense in certain situations but not others. My personal feeling is that GPP 2022 presents high level principles and that experts within specific working settings should be making decisions about what makes sense for that setting, in terms of applying those principles.”

“My personal feeling is that GPP 2022 presents high level principles and that experts within specific working settings should be making decisions about what makes sense for that setting, in terms of applying those principles.”

Would you like to see greater involvement of any stakeholders, such as patients, in the development of future GPP guidelines?

“My personal feeling is that we really need a patient-led document on publications that outlines what patients would like to see, similar to the article written by Hesp et al on applying GPP3 in the Asia–Pacific region, taking GPP3 principles and translating them to the regional context.

It would also be nice to see work from stakeholders in low- and middle- income countries that outlines their views on publications, inclusivity, and good practice.

“It would also be nice to see work from stakeholders in low- and middle- income countries that outlines their views on publications, inclusivity, and good practice.”

I’d also like to see what experts in various scientific and medical specialties might recommend to their members.”

What do you predict is next for GPP? Which topics may need to be covered in future iterations of the guidelines as the publications landscape evolves?

“I sincerely hope this iteration lasts for several years. The next steps I foresee are answering any FAQs and identifying areas that need attention. For instance, there seems to be some question about how many steering committees to have. GPP 2022 covers several possibilities and I think day-to-day experts, of whom there are many, should share their experiences. As a next step, I also see various groups commenting on how they apply GPP principles in various working contexts. It would be especially helpful, for instance, to hear more from people working in low- and middle-income countries about the needs for training or support to enable inclusion in steering committees and authoring teams. As noted, I also believe that we need to hear more from patients—there are some publications on how to form a patient steering committee, for instance, but there seems to be a space for more work, such as how to help patients participate in peer review.

We anticipated that artificial intelligence and other technological advances will impact publications and that journals will enhance their policies on preprints. These should not affect the main principles of GPP, though, I would hope.”

 Lisa DeTora is Associate Professor at Hofstra University. You can contact Lisa at lisa.m.detora@hofstra.edu or on LinkedIn.

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