Data sharing – The Publication Plan for everyone interested in medical writing, the development of medical publications, and publication planning https://thepublicationplan.com A central online news resource for professionals involved in the development of medical publications and involved in publication planning and medical writing. Tue, 12 Aug 2025 12:02:18 +0000 en-US hourly 1 https://s0.wp.com/i/webclip.png Data sharing – The Publication Plan for everyone interested in medical writing, the development of medical publications, and publication planning https://thepublicationplan.com 32 32 88258571 Can adopting AI tools unlock a new era of open science? https://thepublicationplan.com/2025/08/12/can-adopting-ai-tools-unlock-a-new-era-of-open-science/ https://thepublicationplan.com/2025/08/12/can-adopting-ai-tools-unlock-a-new-era-of-open-science/#respond Tue, 12 Aug 2025 12:02:16 +0000 https://thepublicationplan.com/?p=18198

KEY TAKEAWAY

  • Generative AI tools can simplify data sharing through automating metadata creation and flagging missed requirements, ultimately enhancing open science.

Artificial intelligence (AI) has proved transformative in scientific research, from experimental design to assisting publishers and streamlining peer review processes. But can it unlock access to research data, code, and protocols frequently lost behind digital and institutional walls? In a recent London School of Economics Impact Blog article, Niki Scaplehorn and Henning Schoenenberger, both at Springer Nature, describe how generative AI could play a pivotal role in reshaping how data are shared, potentially revolutionising open science.

Hurdles to data sharing

The COVID-19 pandemic marked a turning point for open science, with global collaboration and rapid data sharing accelerating breakthroughs. Yet, Scaplehorn and Schoenenberger highlight that there are still considerable challenges to data sharing:

  • a lack of consistent guidance and struggles to align with FAIR standards
  • confusing and overlapping data sharing policies
  • cultural barriers
  • a lack of recognition for data sharing, code publication, and protocol documentation in academia.

Springer Nature saw compliance with data sharing requirements jump from 51% to 87% simply by asking authors to justify why they hadn’t deposited data prior to article acceptance. Scaling this approach, however, demands time and manpower. According to Scaplehorn and Schoenenberger, here, generative AI shows potential.

How can AI benefit data sharing?

The authors call for a “product” mindset that treats AI open science tools as services designed around researchers’ needs, rather than top-down mandates or administrative burdens. Scaplehorn and Schoenenberger highlight that AI can benefit data sharing through:

  • automation of metadata creation
  • flagging missing documentation and overlooked requirements
  • suggesting best practices to improve workflows.

“Generative AI could play a pivotal role in reshaping how data are shared, potentially revolutionising open science.”

The path forward

Scaplehorn and Schoenenberger believe that adopting AI tools designed around authors’ needs will streamline the burdensome aspects of data sharing. Ultimately, this will benefit researchers, policymakers, and everyone who relies on access to scientific information through lowering the barriers to open science.

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What do you think – can AI be used to increase data sharing?

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Should data sharing be the next checklist item in reporting guidelines? https://thepublicationplan.com/2025/03/11/should-data-sharing-be-the-next-checklist-item-in-reporting-guidelines/ https://thepublicationplan.com/2025/03/11/should-data-sharing-be-the-next-checklist-item-in-reporting-guidelines/#respond Tue, 11 Mar 2025 09:51:52 +0000 https://thepublicationplan.com/?p=17365

KEY TAKEAWAY

  • Data sharing is an essential component of open science. The EQUATOR executive are calling for its inclusion in reporting guidelines.

Mandatory data sharing has been gaining pace in recent years, with data underlying US federally funded research soon needing to be made available immediately on publication. Since its inception in 2006, the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, best known for hosting an online library of research reporting guidelines, has been an important advocate for improving the quality and transparency of medical research reporting. Now, in a recent article for The BMJ, the EQUATOR executive group explain how data sharing could be made standard practice as the next goal for open science.

Are current reporting guidelines sufficient?

The authors describe data sharing as a broad concept, from study registration to protocol availability, then data availability. While many stakeholders have emphasised trial registration and transparency, the requirement to discuss data sharing is missing from most reporting guidelines. A notable exception is a 2020 addition to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklist.

“While many stakeholders have emphasised trial registration and transparency, the requirement to discuss data sharing is missing from most reporting guidelines.”

The EQUATOR executive encourage new or updated reporting guidelines to cover data sharing, to ensure authors:

  • describe data sharing in protocol and results publications
  • are encouraged to share data
  • report on items linked to data sharing, like sharing of code and protocols.

What can authors do now?

While awaiting formal guidance on reporting data sharing, the EQUATOR executive suggest authors include the following in publications:

  • data definition, collection, and management methods
  • manuals or videos used in delivering the intervention
  • the statistical analysis plan, including any coding
  • any barriers to sharing data and other materials from the study.

The EQUATOR executive also encourage authors to adopt the findable, accessible, interoperable, and reusable (FAIR) and collective benefit, authority to control, responsibility, and ethics (CARE) principles when sharing data.

What’s next?

Beyond reporting guidelines, the authors signpost journal policies, funder expectations, and research assessment criteria as avenues to drive increased data sharing. They also point to data management and sharing plans, and suggest an opportunity for the EQUATOR Network to provide guidance on reporting these in a standardised way to further boost data sharing.

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Do you routinely include data sharing statements in your publications?

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Uncovering scientific ERRORs: can financial rewards work? https://thepublicationplan.com/2024/10/31/uncovering-scientific-errors-can-financial-rewards-work/ https://thepublicationplan.com/2024/10/31/uncovering-scientific-errors-can-financial-rewards-work/#respond Thu, 31 Oct 2024 14:41:54 +0000 https://thepublicationplan.com/?p=16715

KEY TAKEAWAYS

  • The ERROR project pays reviewers to search for mistakes in the scientific literature, while rewarding authors who agree to participate.
  • Reviewers and authors receive bonuses depending on the extent of errors found.

Amid rising retraction rates, the scientific record is increasingly scrutinised for signs of research misconduct like fabrication and image manipulation. But what about detecting errors in the data underlying scientific publications?

The ERROR project

Modelled on tech company ‘bug bounty’ programmes, the Estimating the Reliability & Robustness of Research (ERROR) project offers cash rewards for reviewers identifying incorrect or misinterpreted data, code, statistical analyses, or citations in scientific papers. Following ERROR’s launch earlier this year, Julian Nowogrodzki reviewed the project so far in a recent article in Nature.

Professor Malte Elson and colleagues are aiming to produce a blueprint for systematic error detection that will be scalable and transferable across scientific fields. Starting with highly cited psychology papers, the first review was posted in August. ERROR plans to cover 100 publications over 4 years, expanding into artificial intelligence, medical research, and potentially preprints.

“The ERROR project offers cash rewards for reviewers identifying incorrect or misinterpreted data, code, statistical analyses, or citations in scientific papers.”

Financial incentives

The project has 250,000 Swiss francs (~£220,000) of funding from Professor Elson’s institution, the University of Bern. Reviewers can earn up to 1,000 Swiss francs each time, plus a variable bonus of up to 2,500 Swiss francs depending on the scale of errors identified. Authors receive up to 500 Swiss francs: 250 for agreeing to participate and sharing data, plus a bonus if minimal errors are found.

A challenging path

Despite the incentives, ERROR has hurdles to overcome:

  • Author buy-in: So far, authors from just 17 of 134 selected papers have agreed to participate.
  • Data access: Underlying data may have been lost or authors may cite legal reasons barring sharing.
  • Reviewer expertise: There are limited potential reviewers with sufficient technical expertise yet no conflicts of interest. Dynamics linked to seniority may also prevent some prospective reviewers taking part.

The ERROR team hopes to convince research funders to allocate money for error detection – ultimately saving them from investing in flawed research. We look forward to seeing how this project helps move the needle towards a more reproducible scientific record.

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Do you think current ‘ad hoc’ approaches to error detection in the scientific record are sufficient?

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Hybrid events: a sustainable future for academic conferences? https://thepublicationplan.com/2023/11/21/hybrid-events-a-sustainable-future-for-academic-conferences/ https://thepublicationplan.com/2023/11/21/hybrid-events-a-sustainable-future-for-academic-conferences/#respond Tue, 21 Nov 2023 13:43:44 +0000 https://thepublicationplan.com/?p=14770

KEY TAKEAWAYS

  • Conferences moved to an online-only or hybrid format due to the COVID-19 pandemic, presenting both new benefits and new challenges.
  • Academic societies and organisations now have an important opportunity to evolve the format of their conferences to better meet the needs of their members.

Conferences have long been the mainstay of community and an important means of data dissemination for academic societies and organisations. However, until recently, conferences have largely followed the traditional format of annual in-person meetings. This all changed in the wake of the COVID-19 pandemic, which forced organisers to adopt virtual event formats. In a recent article for The Scholarly Kitchen, Paul Killoran discussed what the future might hold for academic conferences.

While it is undeniable that face-to-face events remain ideal for networking, they also come with significant challenges. Participants may face financial, political, and logistical barriers to attendance; therefore, the impact of conferences has generally been limited to the relatively small number of attendees who are able to meet in person. In addition, there is increasing awareness of the impact of international travel on climate change. A hybrid format of smaller, regional face-to-face events combined with online tools to provide a global reach offers a more sustainable alternative to one large annual meeting.

A hybrid format of smaller, regional face-to-face events combined with online tools to provide a global reach offers a more sustainable alternative to one large annual meeting.

A range of hybrid formats are beginning to emerge, using different combinations of in-person and virtual presentation, discussion, and networking sessions. This presents a challenge in itself, as no one hybrid model will work effectively for all events. Societies and organisations will need to figure out how to leverage online tools to maximise their reach whilst balancing costs and maintaining value for participants.

It is clear that there is no ‘one size fits all’ for conferences and that both in-person and virtual formats will play a role moving forwards. We hope to see organisations identifying and addressing their individual needs and adopting targeted methods to communicate effectively with their members.
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Which format would you prefer future academic conferences to follow?

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Immediate open access to research data: a federal mandate and much debate https://thepublicationplan.com/2023/10/10/immediate-open-access-to-research-data-a-federal-mandate-and-much-debate/ https://thepublicationplan.com/2023/10/10/immediate-open-access-to-research-data-a-federal-mandate-and-much-debate/#respond Tue, 10 Oct 2023 08:17:46 +0000 https://thepublicationplan.com/?p=14513

KEY TAKEAWAYS

  • From the end of 2025, US government policy will mandate immediate open access to federally funded research data and publications, eliminating the current 12-month embargo.
  • While further details on implementation are worked out, publishers, funders, and researchers grapple with the best ways to fund open access.

A year ago, the US White House announced plans to make all federally funded research immediately available for free by the end of 2025. So, what progress has been made, and what will this model mean for the status quo in medical publishing?

The mandate from the White House Office of Science and Technology Policy (OSTP) instructed all federal agencies to implement plans to “deliver transparent, open, secure, and free communication of federally funded research and activities”. Under the new directive, publications must be made instantly available to the public, removing the current optional 12-month grace period. In line with a similar mandate from the WHO, the directive also applies to research data.

The mandate from the White House Office of Science and Technology Policy (OSTP) instructed all federal agencies to implement plans to “deliver transparent, open, secure, and free communication of federally funded research and activities”.

The OSTP left it to federal funding agencies to work out the finer details of implementation, which led to a flurry of debate on the policy’s potential impact and how best to enact it. Publishers raised concerns around what they viewed as a lack of consultation and financial sustainability, while the US government pointed to the success of Plan S in Europe, as well as the rapid open access to research seen during the COVID-19 pandemic.

What will this mean for medical publishing?

In an economic assessment report, the OSTP predicted that the policy would lead to changes in publishers’ business models. The move to immediate open access will inevitably make journal subscription models less desirable, and publishers’ incomes will likely become more reliant on the article processing fees levied on open access publications. As reported by Susan d’Agostino of Inside Higher Ed, this raises the question of who will bear these costs. The OSTP allows researchers to “include reasonable publication costs” in their budgets, but some researchers point out that budget squeezes may follow, with open access fees impacting on funds available for other aspects of research.

Following the policy launch, the OSTP held a Year of Open Science, with federal funding agencies obliged to submit initial updated public access plans over the course of 2023. Large funders, such as the National Institutes of Health, have already done so. The year also incorporated 4 ‘listening sessions’ with early-career researchers. These researchers advocated for a broader range of initiatives to ensure:

  • equitable access to open access publishing
  • incentives for open science, rather than the current ‘publish or perish’ environment
  • better use of alternative avenues for early research dissemination, such as preprints.

Meanwhile, some publishers and other bodies advocate for alternative models, such as:

So, what’s next?

Questions remain for publishers, and the road to more fully open access models can be rocky. While the European Plan S initiative is much more advanced, having been in effect since 2021, cOAlition S recently announced that a number of hybrid journals will be dropped from its funded transformation programme, because they failed to make quick enough progress towards full open access. In the case of the US policy, an analysis by Eric Schares found that 265,000 articles a year could be affected, and that some publishers would be impacted more than others.

As work continues through to 2026, we watch with interest to see how the publishing ecosystem will adapt to this change in the landscape.

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What do you think – will we see a move away from journal subscription models?

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Monitoring open science: what key practices should we measure? https://thepublicationplan.com/2023/07/18/monitoring-open-science-what-key-practices-should-we-measure/ https://thepublicationplan.com/2023/07/18/monitoring-open-science-what-key-practices-should-we-measure/#respond Tue, 18 Jul 2023 10:30:23 +0000 https://thepublicationplan.com/?p=14180

KEY TAKEAWAYS

  • Stakeholders at biomedical research institutions agreed on 19 key open science practices that should be monitored to help institutions track their progress.
  • Selected open science practices include prospective registration and timely reporting of clinical trials, specifying information to be shared, publishing open access, and disclosing author and funder information.

Open science aims to improve the quality and reproducibility of research through increasing transparency and accessibility. Following the 2021 adoption of the United Nations Educational, Scientific and Cultural Organization (UNESCO) Recommendation on Open Science, the US National Institutes of Health (NIH) and World Health Organization (WHO) have also introduced data sharing policies. ‘Success’ in open science generates effective research outcomes, reduces costs, and improves reputation. However, questions remain on which practices are the most important and how they should be monitored.

A recent publication in PLoS Biology shared results from a 3-round Delphi study asking which open science practices should be monitored at biomedical research institutions globally. 80 participants, including researchers, open science specialists, and librarians, contributed to the study. They reached consensus on 12 traditional and 7 broader transparency practices that should be monitored, including several also assessed in PLOS’ Open Science Indicators initiative.

The key open science practices were related to:

  • registration and timely reporting for clinical trials and systematic reviews
  • information sharing, eg, stating whether data, study materials, or code were shared openly at the time of publication, and the use of clear licences for any shared information
  • use of persistent identifiers, including ORCID identifiers for researchers and digital object identifiers (DOIs) for shared data, study materials, or code
  • use of open access publication (including whether open access is immediate or delayed)
  • disclosure of author contributions, conflicts of interest, and funding.

Dr Kelly D. Cobey and co-authors now plan to develop a fully automated open science dashboard interface, incorporating the agreed core open science practices where these can be measured accurately and reliably. Dr Cobey and co-authors believe the tool will allow institutions to track their progress adopting open science practices and adhering to mandates, and that it will facilitate open science meta-research, without evoking competition or indicating prestige at the institutional level.

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What do you think – would institutions benefit from an automated dashboard to monitor open science progress?

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Challenging the status quo in medical communications: an interview with James Dathan https://thepublicationplan.com/2023/06/15/challenging-the-status-quo-in-medical-communications-an-interview-with-james-dathan/ https://thepublicationplan.com/2023/06/15/challenging-the-status-quo-in-medical-communications-an-interview-with-james-dathan/#respond Thu, 15 Jun 2023 10:00:53 +0000 https://thepublicationplan.com/?p=14019

In today’s digital age there is an opportunity to present and share medical research in new and creative ways. However, traditional formats are often still our go-to methods. Following his participation at the 2023 International Society for Medical Publication Professionals (ISMPP) EU meeting, The Publication Plan spoke with James Dathan, Global Publications Manager at AstraZeneca, to learn why he feels it is time to challenge the status quo and how we should be striving to develop more innovative ways to communicate medical information.

With social media and various digital platforms, there are many formats available for sharing data and research. At the 2023 European Meeting of ISMPP you talked about using an omnichannel approach to communication. For anyone unfamiliar with the concept, could you explain what this means and how it differs from a multichannel approach?

“A quick Google search shows that omnichannel is referred to as ‘a neologism describing a business strategy’ while the business consulting firm Frost & Sullivan defines it as ‘seamless and effortless, high-quality customer experiences that occur within and between contact channels’. While this overview is helpful, it is trying to explain something that I do not think anyone really knows yet ─ omnichannel is a relatively new concept and what will become its defining characteristics are still evolving.”

Multichannel in my view refers to standard communication methods, such as journals, congresses, and the more traditional methods of dissemination. Omnichannel simply enhances those for the modern world where we all connect to phones, social media and e-mails whenever we want. To this end the opportunity to reach anyone, on any platform is omnipresent – we just need to pick the right platforms and the right processes. What we think of as omnichannel communication  and how we see its potential and direction may change tomorrow and certainly will in the future.”

“The opportunity to reach anyone, on any platform is omnipresent – we just need to pick the right platforms and the right processes.”

Specifically, within medical communications, what are the benefits and challenges to pharmaceutical companies adopting omnichannel strategies? Could you share any examples of this approach being utilised particularly effectively at AstraZeneca?

“Keeping pace with technological developments is a massive challenge. By the time we have identified an opportunity and started exploring, embracing, and actioning ideas, the world has moved on. So few opportunities exist for a sustained period during which we can try out new platforms (remember MySpace!). Other, more enduring areas which we can explore, such as Twitter, Facebook and TikTok are restricted by the PMCPA, our own compliance guidelines and concerns that posts may be interpreted as promotional rather than informative. Our job in publications is to bridge the gaps between the science, healthcare professionals (HCPs) and patients, making information accessible, relatable, and useful for people living with illness and disease. To do this we need to challenge the status quo and overcome concerns about self-promotion. We need to work with agencies such as PMCPA and other pharmaceutical companies to share the breath-taking work being done by the scientific teams with patients, who simply want to know and understand the illnesses they are dealing with.”

At the European Meeting of ISMPP, you highlighted the need to challenge standard practices and used congress posters as an example of a format that has changed very little over time. What do you think are the main barriers to pharmaceutical companies using more innovative approaches to communication? Could you share any examples of projects that you have been involved with where new or creative ideas were used successfully?

“As with social media I think that compliance and our own caution with regards to compliance has a part to play. Moving away from familiarity takes courage and a sustained effort. I talked about Better Poster 2.0 being around for years already… where are the next evolutions, 3.0 etc? We have added features to posters such as plain language summaries (PLS) and QR codes but kept the existing format. A few years ago, when I was with an agency, I led an interactive poster project with our client and the main battle we faced was being able to present the poster differently. Of the three or four models we suggested, the safest and most familiar was selected. I didn’t even want to put this model forward as the whole point of the project was to move away from the standard format. As a result, the poster did not stand out, did not look new or innovative and the metrics were, at best, rubbish!

“To drive innovation, we need to get everyone on board from the outset, including the congresses.”

To drive innovation, we need to get everyone on board from the outset, including the congresses, as so often they insist on font size, content etc. Would a poster be so bad if it only included results and/or a conclusion with the other details sitting behind a QR code for transparency? – it may even drive more people to use the QR code!”

During the last couple of years, medical congresses had to take place virtually due to the COVID-19 pandemic. Do you feel the shift to virtual events encouraged innovation? Do you think the change in format resulted in any advantages that should continue to be incorporated at face-to-face events?

“QR codes as a way of putting content online were all the rage during COVID. However, the industry defaulted to what it so often does and decided that talking head videos would be the way forward. So, everyone did the same… Sometimes we need to ban the normal to force innovation. The pandemic forced people to finally embrace the idea of a 3-dimensional poster, where more content can sit behind it via a QR code. The idea of going further to create 4 dimensions where live discussions with the authors  take place behind the QR code can now be a real option going forward.

This could even lead to reducing the industry’s carbon footprint with fewer people travelling thousands of miles to present a poster for 15 minutes. We are in a real digital age, and we must embrace it. Yes, face-to-face interactions are crucial and have a place, but just because we can go back to face-to-face meetings, doesn’t mean that we must. It doesn’t mean that we must throw away a lot of the wider opportunities created during the pandemic and press a reset back to ‘how it’s always been’. Maybe posters should become more focused on critical and key content, with the author taking part in discussions from their  office, via a large, centrally placed QR code. Or maybe discussions could even occur via holograms through augmented reality.”

“We are in a real digital age, and we must embrace it. Yes, face-to-face interactions are crucial and have a place, but just because we can go back to face-to-face meetings, doesn’t mean that we must.”

Journals are increasingly offering additional digital features to go alongside traditional articles. How do these enhancements improve the reach and impact of research? How do you go about measuring the return on investment?

“We are currently looking at this as a team. We are redoing our metrics projects, developing what we use already from Altmetric data, and working alongside that team to develop a Share of Voice dashboard where we can access the qualitative data, aligned with our quantitative data to get a more balanced view of the impact being made by content. We encourage the industry to move away from defaulting to impact factor as the sole consideration in journal selection and push for  open access and digital support, which can make papers more accessible to a wider audience and provide a better understanding of what people are accessing and saying about our articles. This improved analysis can then drive journal selection (and subsequent review of the selection) going forward to better educate teams about the opportunities that exist outside of simply looking at impact factor.”

“We encourage the industry to move away from defaulting to impact factor as the sole consideration in journal selection.”

Patient inclusion in medical communications was another key topic at ISMPP EU. An omnichannel approach to data dissemination provides scope to reach patients via a variety of media and increase patient involvement. Have you found this to be the case? How important is this aspect of the omnichannel approach and what do you think are the key considerations when involving patients?  

“The whole point of omnichannel is to allow and encourage patients to be able to find information on both their illness and treatment options to inform and support them. That’s why we are all here, to support patients through difficult times. As I said above, omnichannel is an ever-evolving concept due to the pace of media and channel development. What we think of it today, how we see its potential and direction may change tomorrow and certainly will in the future. This point really brings together many of the questions above whereby evolution can only occur in this space if every stakeholder gets on board. One limiting area will derail it all and revert back to the tried, tested and safe standard.

We need social media guidance from the PMCPA to be available for some level of dissemination. If we created non-promotional language and informed people of everything that is available, it would become easier for patients to find research. Removing pay walls and accessibility to patients would make a huge impact too and this will only happen with companies working together to get the best outcomes for patients to be reassured, and understand the progress and options available to them.

Involving patients in the publications process is increasingly common and finally being recognised as valuable. Patient involvement allows for articles to have an empathetic and practical sense. Our language can all too often be very scientific, hard, and factual without the secondary consideration/realisation that patients will be reading our articles too, not just HCPs! Involving patients can provide a human centric approach to the writing resulting in more descriptive and informative wording and improved accuracy of language – often opening the article to more patients who will get what they came looking for from the article.”

PLS, which are recommended in the GPP 2022 update, are mandated by some pharmaceutical companies for some or all their company-sponsored research. What is the current policy on PLS at AstraZeneca? How do you think decisions should be made regarding the inclusion of PLS to maximise their benefit whilst avoiding cherry picking research?

“The simple solution is to mandate that all publications need a PLS. This is something that I think will come but needs to be done in line with PMCPA considerations regarding social media, otherwise we are once again creating a bottleneck of content without a proper and full distribution system available.

PLS are improving and becoming  much more regulated and relevant as the social media world wants bitesized, simple content to understand. Even posters are now ‘too much’ to digest for people; instead they want to access information that has been summarised in a PLS. I go back to point raised above: so much more information could sit behind a poster with QR codes or other digital mechanisms with a concise text summary of the conclusion, a PLS and some simple graphics on the poster.

We are developing PLS options with internal artificial intelligence (AI) tools at present. We have made some fantastic progress on this with posters and are keen to extend the potential to manuscripts and even develop full plain language summaries of publications (PLSPs) in the future using this potential technology. More to come!”

Looking to the future, what developments would you like to see within medical communications? Are there any areas where you feel innovations or more creative approaches may lead to significant changes to standard practices?

“We can be a creative sector of the industry. We want to be creative and be pushed harder to innovate and create. Some of the issues right now are simply that the constraints around what is seen to be ‘promotional’ are so tight that it makes it incredibly hard to be creative! There are always new ways of doing things and as an industry that is constantly innovating and pushing boundaries within science, we seem very slow to be open-minded enough to challenge the status quo within the communications space. There is so much we could do, that does not need to be promotional, but can be informative, reassuring, and supportive for patients – we just need to work collaboratively to remove obstacles and find a mutually agreeable pathway to allow more and better innovation in the publications space.”

“We can be a creative sector of the industry. We want to be creative and be pushed harder to innovate and create…..There is so much we could do, that does not need to be promotional, but can be informative, reassuring, and supportive for patients.”

James Dathan is Global Publications Manager at AstraZeneca and can be contacted via james.dathan@astrazeneca.com or LinkedIn. James Dathan is an employee of AstraZeneca. This article reflects his opinions and not necessarily those of AstraZeneca.

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In your experience what is the most common approach to developing a congress poster?

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FAIR principles for research software: a step forwards in discoverability https://thepublicationplan.com/2023/04/04/fair-principles-for-research-software-a-step-forwards-in-discoverability/ https://thepublicationplan.com/2023/04/04/fair-principles-for-research-software-a-step-forwards-in-discoverability/#respond Tue, 04 Apr 2023 12:03:09 +0000 https://thepublicationplan.com/?p=13526

KEY TAKEAWAYS

  • The FAIR (‘findable’, ‘accessible’, ‘interoperable’, and ‘reusable’) principles of data management have now been applied to the development of research software.
  • The FAIR for Research Software (FAIR4RS) principles have been published alongside practical illustrative examples, to give researchers clear guidance on their implementation.

Despite the publication of the FAIR (‘findable’, ‘accessible’, ‘interoperable’ and ‘reusable’) principles of data management in 2016, data discoverability continues to be a challenging field, hampered by issues such as lack of awareness and inadequate implementation. An article by Michelle Barker et al in Scientific Data outlines how FAIR principles can be applied to the development of research software, to improve data management and stewardship.

FAIR principles can be applied to the development of research software, to improve data management and stewardship.

Developed by the FAIR for Research Software (FAIR4RS) working group, the FAIR4RS principles recommend that software and, when relevant, associated metadata are:

  • Findable: simple for humans and machines to find, including via a unique identifier, and described by rich metadata
  • Accessible: retrievable using standardised protocols
  • Interoperable: interoperable with other software and/or by application
  • Reusable: “Can be understood, modified, built upon, or incorporated into other software”.

The authors provide three real-life examples of the successful implementation of the FAIR4RS principles, to give researchers clear, practical guidance:

  1. A command-line toolComet is an open-source tool. The details of its development, its metadata, and the software itself are all freely available and findable.
  2. Complex research software: The software PuReGoMe analysed real-time data on public attitudes during the COVID-19 pandemic. The software has a unique identifier and independently accessible metadata that are searchable and indexable.
  3. Graphical user interfaces: gammaShiny is available in a national archive under a public licence and has a persistent unique identifier.

The aspirational FAIR4RS principles provide a means to further improve the transparency and reproducibility of research. To ensure their effective implementation, software owners and developers should consider the principles early in the development process.

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What do you think – will the FAIR4RS principles help improve discoverability?

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Evidence-based policy generation: how can we improve on open access? https://thepublicationplan.com/2023/02/14/evidence-based-policy-generation-how-can-we-improve-on-open-access/ https://thepublicationplan.com/2023/02/14/evidence-based-policy-generation-how-can-we-improve-on-open-access/#respond Tue, 14 Feb 2023 17:35:36 +0000 https://thepublicationplan.com/?p=13207

KEY TAKEAWAYS

  • Sarah Chaytor presents a framework for strengthening evidence-based policy generation.
  • Key elements of the framework are cross-functional collaboration, fostering relationships, and making research outputs clear and accessible.

In August 2022, following a roundtable discussion hosted by the Higher Education Policy Institute (HEPI) and Taylor and Francis, Sarah Chaytor (Director of Research Strategy & Policy at University College London) developed a framework for improving the relationships between research institutions and public policymakers. This framework, dubbed the ‘Five Cs’, acknowledges the current limitations of open access.

Capabilities

This first ‘C’ deals with how to effectively communicate, access, and understand research, and includes translation capabilities (to make academic research understandable for lay audiences) and curational capabilities (to make research outputs easy to find and navigate for users). Chaytor also highlighted relational capabilities, which are a key element in supporting research use.

Connections

Chaytor discussed the role of relational capabilities in more detail in the second ‘C’ and stressed the importance of investing in building sustainable, long-term relationships to ensure successful academic-policy engagement.

Coordination

Long-term relationships can help to foster coordinated research efforts. Chayton noted that literature reviews are highly valued by policy users for providing accessible evidence summaries, but tend to be undervalued by funders and publishers. In the future, it will be important to find ways to encourage timely research synthesis as part of academic outputs.

Collaboration

While the COVID-19 pandemic demonstrated the importance of cross-disciplinary approaches to policy issues, Chaytor believes that collaboration should be between organisations as well as between disciplines. An illustrative example of institutional collaboration is the Universities Policy Engagement Network (UPEN) – a community of UK universities that aims to increase the impact of research on policy and offers a collective response to requests for evidence from policymakers.

“Supporting sustained collaboration between academic, policy, and other communities is essential to drive evidence use” – Sarah Chaytor

Co-production

The final ‘C’ focuses on the effective co-production of evidence between the academic and policy communities. Chayton suggested a ‘quadruple helix’ approach to co-production, which would also include businesses and civil society.

We hope to see the elements in this framework being implemented to facilitate evidence use and better support evidence-informed policymaking.

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What do you think – will the ‘Five ‘Cs’ presented here help improve on open access for evidence-based policy generation?

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Meeting report: summary of Day 2 of the 2023 ISMPP European Meeting https://thepublicationplan.com/2023/02/09/meeting-report-summary-of-day-2-of-the-2023-ismpp-european-meeting/ https://thepublicationplan.com/2023/02/09/meeting-report-summary-of-day-2-of-the-2023-ismpp-european-meeting/#respond Thu, 09 Feb 2023 14:37:19 +0000 https://thepublicationplan.com/?p=13158

The 2023 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 24–25 January. The first in-person European Meeting since 2020, themed ‘Fueling Creativity’, saw a record 360 delegates in attendance.

A summary of the second day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

A summary of the first day of the meeting can be found here.

Summaries of Day 2

Day 2 opened with parallel sessions, with attendees each having the opportunity to select 2 sessions to attend.

Parallel session: A balancing act: creativity and industry compliance


KEY TAKEAWAY

  • Creative solutions that aim to improve data accessibility, transparency, and patient engagement come with risks, but are achievable with rigorous risk assessment.

In this parallel session, Geraldine Drevon (GSK), Christine Vanderlinden (GSK), Catherine Skobe (Pfizer), Veronica Porkess (UCB), and Jonas Lind Hansen (Novo Nordisk) explored the balance between industry regulations and creativity that must be navigated to address evolving needs for scientific dissemination.

Independent platforms
The first part of the panel discussion focused on scientific dissemination on independent (ie non-industry-sponsored) platforms, such as figshare. Vanderlinden was tasked with identifying risks: lack of control over who can access the data and how the materials are used, the potential for varied quality of data posted on such sites, and how companies should compliantly decide which data are (and are not) uploaded. Despite these risks, Skobe shared a case study demonstrating how Pfizer has successfully developed a process to use figshare to publish manuscript plain language summaries (PLS), ensuring all content is peer reviewed and can be linked to the journal article using a digital object identifier (DOI). After a successful pilot, they plan to expand the process for other uses, such as enhanced publication content, further supplementary information, and eventually as a green open access repository.

Industry-sponsored platforms
The next topic in the session was use of industry-owned platforms. While some risks are similar to those for independent platforms, Porkess discussed further potential issues related to copyright and balancing access versus promotion of data (eg if someone scans a poster QR code, is it appropriate for users to be able to access other posters from that link?). Hansen provided some guidance on these platforms from a legal perspective, advising that the perception of company-owned websites being promotional is false – if content is objective and meets the same criteria as other publications (including in terms of copyright), then such sites are a viable solution for sharing enhanced content, if journals and congresses do not offer the possibility. Hansen emphasised the need to involve legal and compliance teams throughout the process, not just at the end. A case study from Novo Nordisk showed the process of building a freely accessible scientific exchange platform (Science Hub) to address the varied communication preferences of today’s healthcare professionals (HCPs). Novo Nordisk use the platform to house manuscripts or links to manuscripts, publication extenders, congress presentations, and medical education materials, which are all rigorously assessed for compliance before being uploaded.

The perception of company-owned websites being promotional is false – if content is objective and meets the same criteria as other publications…then such sites are a viable solution for sharing enhanced content.

Industry involvement with patients
Finally, the panel discussed the involvement of patients in scientific publications. Vanderlinden explained how to mitigate potential risks associated with patient authors for industry-sponsored manuscripts, including:

  • the importance of careful assessment of why patients should be involved (it may not make sense for every publication)
  • involving patients from the evidence generation step onwards, rather than when considering publication
  • preparing patients to help them provide meaningful feedback on publications.

As raised in the fireside chat session on Day 1, payment of patient authors remains a challenging topic in the industry, with varied processes and policies at different pharmaceutical companies. A final case study from UCB showcased a successful partnership with patients to develop a manuscript on the lived experience with a disease. The protocol was designed in collaboration with a patient council, analysis of key themes was patient-led, and patients were included as authors of both a poster and a peer reviewed manuscript, in accordance with International Committee of Medical Journal Editors (ICMJE) criteria.

The Q&A session following the panel discussion raised some interesting points, including:

  • the importance of developing industry guidelines for digital platforms and partnering with patients, to help improve uptake by risk-adverse companies
  • the concept of a ‘professional patient’ who may work with multiple pharmaceutical companies (and therefore may be considered more objective), but may create challenges for appropriate payment
  • criteria for selecting appropriate publications for patient authorship remain to be defined, with suggestions including active participation in study design, or a topic such as quality of life.

Parallel session: Connecting the dots – turning information into insights


KEY TAKEAWAYS

  • Insights are the combination of information and context, and need to be actionable (aligned with strategic goals) and managed in an ongoing process.

Belinda Dean (3 Stories High) moderated this session, which focused on how insights gathered from external stakeholders can be used to inform strategic planning.

Kicking off the presentations, Sharon Suntag (IQVIA) explained that while information can be gathered from multiple sources, adding context is what provides the insight. Suntag summarised the ‘cycle of insights’:

  • Interrogating data sources: these are unrefined facts.
  • Assessing the information: what is happening?
  • Forming the insights: adding context.
  • Producing an actionable insight: what to do.

Suntag highlighted that strategic goals need to be considered when moving through this process. Suntag also highlighted that data lakes might contain information that is:

  • structured – available in a table format that is defined and searchable and has been developed for a specific purpose
  • unstructured – qualitative data, website content, presentations, medical data such as lab reports, or imaging.

Suntag emphasised that it is important to use the most appropriate data when developing questions to drive insight generation, and that different data sources are needed to ask questions of different key stakeholders.

Laura McGovern (Nucleus Global) then provided an agency perspective on a schematic approach to insights-driven medical planning. McGovern discussed a  project which captured cross-functional insights based on a small data lake. Initially, insights were collated and evaluated against the medical objectives. McGovern highlighted that the quality of different sources needs to be carefully weighed – for example, social media may be fraught with fraudulent posts. Using a digital dashboard can optimise the efficiency of collecting insights at this stage. Once insights were gathered, a cross-functional workshop was held to align on priority actionable insights. A core group then worked to build an action plan (including timeframes and roles and responsibilities). The plan was then implemented, and its success evaluated through the collection of metrics. McGovern noted that the process of insights-driven medical planning is circular, with additional insights gathered and the plan amended as needed.

The final speaker in this session was Clare Baker (Idorsia). Baker shared that the insights-driven medical communications planning process at Idorsia begins with medical objectives and involves alignment of questions and listening priorities across countries and regions. The process was framed as follows:

  • Insight gathering: insights are gathered from medical science liaisons (MSLs) using Customer Relationship Management platforms, medical information requests, and ad boards.
  • Insight analysis: this ongoing process includes manual activities and artificial intelligence (AI) approaches, such as Microsoft Power BI.
  • Insight reporting: at Idorsia, this is manually led by the Medical Operations function to identify insights that can inform product and communications strategies.
  • Insight actioning: determined by cross-functional review.

Baker explained that cross-functional collaboration and sharing feedback are key to the success of insights-driven medical communications planning. Partnerships with agencies can also help with implementing insights within strategic and communications plans.

Cross-functional collaboration and sharing feedback are key to the success of insights-driven medical communications planning.

Parallel session: Publications without borders: harmonising local and global planning


KEY TAKEAWAYS

  • Understanding local needs and priorities will help global publication leads to integrate local publications into the global plan; open communication is key to achieving this.

Maria Haughton (AstraZeneca) chaired this session, and also presented slides on behalf of Michael Sheldon (GSK) who was unable to attend. Tom Grant (UCB) and Anisha Mehra (Ferring Pharmaceuticals) completed the panel, sharing perspectives on challenges and best practices for developing publication plans that integrate global and local priorities. Despite the differences in company sizes, common themes emerged.

The panel all acknowledged the importance of local publications to augment the global plan. Different countries may have different medical priorities and products may have different launch times; local publications can target these specific needs. However, local teams often face resource and time challenges. Small teams are often responsible for multiple products and therapy areas, and often, publications are at the bottom of a very long priority list. Local teams might also be siloed from global, and not aware of processes. High staff turnover at a local level also means that existing knowledge on process is lost, which can translate to challenges for global publications leads, eg last minute requests, ‘surprise’ publications, and the risk of non-compliant publications when processes are not followed.

The panel (and the audience during the Q&A) had some practical recommendations to ensure best practice for local engagement in publication planning. Collaboration was key –a regular call with local teams is a very simple way to keep global informed about local priorities and plans and vice versa. Further, engaging with local teams in a meaningful way is important. This could be through involvement in publication planning workshops. Regular training should be carried out, with the use of case studies to illustrate the benefits of publication planning, as well as the development of clear processes and standard operating procedures (SOPs). The local point of view can also go beyond medical priorities and may impact how publications are delivered – for example, when considering whether local or global agencies should be employed, it is important to consider the preference of the local teams. The recommendations all came back to one core issue: open (and two-way) communication. Engaging with local needs and priorities will help global publication leads integrate local publications into the global plan in a meaningful way, that is beneficial for all.

The recommendations all came back to one core issue: open (and two-way) communication. Engaging with local needs and priorities will help global publication leads integrate local publications into the global plan in a meaningful way, that is beneficial for all.

Parallel session: Guided poster tour

Attendees also had the opportunity to attend a guided poster tour, which visited 4 posters:

  • Accessibility of scientific information for non-English speakers: using browser-based tools to translate plain language summaries (PLS) and abstracts.
  • Ghosts in the machine: retracted articles still haunt the literature.
  • Diversity in medical publications: a cross-sectional evaluation of COVID-19 vaccine research.
  • Evaluating the publication of randomised controlled trials in inflammatory bowel disease by trial outcome and journal attributes.

Once upon a time… Effective storytelling in an age of omnichannel communication


KEY TAKEAWAY

  • Providing a clear, succinct, and aligned narrative using a variety of formats, across different channels and to a broad, cross-functional audience requires advanced planning but is a vital component of effective scientific storytelling.

Chaired by Caroline Halford (Springer Healthcare), the ever-growing role of omnichannel communication for effective storytelling was discussed in this plenary session. Despite great changes in communication methods over the past 20 years, succinct and engaging content that maintains scientific integrity continues to underpin effective communication across multiple types of media. Omnichannel communication is a vital component of this: a holistic method to share preferred content in preferred formats, that takes into account the readers’ perspective and delivers what they want to read.

The new normal: bitesize information needs

Nathalie van Havre (European Hematology Association) kicked off the session with a staggering statistic: since 1950, medical knowledge doubling time has decreased from 50 years to just 73 days. Efficient communication needs to adapt, harnessing different methods of learning.

Van Havre noted that microlearning is a simple and cost-effective addition to an educational strategy. Delivering scientifically sound information in a variety of formats, microlearning keeps learner fatigue at bay. At EHA, microlearning is used to deliver key topics of interest to an audience that spans 100 countries, through initiatives such as ‘Learning Mondays’, ‘Thinking Thursday’, and more in-depth case studies. Describing some key elements of a successful microlearning piece, van Havre highlighted the importance of interactivity, linking out to relevant sources, using a mixture of words and pictures, and encouraging a transferable, systematic thinking process.

Creative storytelling across communications

Fiona Thomas (KPMG) explained that storytelling doesn’t just happen at a single point in time. A great story is one that is retold over and over, and stories must align, complement, and build on one another across the various formats of communication. In scientific storytelling, a clear and aligned narrative needs advance planning and must be developed with a broad audience in mind.

Thomas also noted that a scientific story should be complete regardless of the journey the consumer has taken. She shared some key takeaways:

  • Content and clarity are key.
  • Profile your learners, not HCP type.
  • Scientific storytelling is a relay: build the story and plan for the unexpected.

In scientific storytelling, a clear and aligned narrative needs advance planning and must be developed with a broad audience in mind.

Getting attention in the digital age

In the final presentation of the session, James Dathan (AstraZeneca) challenged the standardised processes in scientific storytelling. Using posters as an example, the format of scientific communication has changed little, despite user feedback showing a clear preference for infographic presentation of data. The use of omnichannel communication, including QR codes, allows readers to choose whether to delve more deeply, and even virtually connect with presenting authors, allowing posters to highlight the main results and conclusions. Dathan noted that in an age of digital adoption, front and centre information is no longer necessary, and innovation should be the motivator for change. Concluding, Dathan underscored the need for collaborative co-creation of scientific stories that embrace omnichannel communication.

The Q&A session also raised some interesting points:

  • Collaborative co-creation of digital content is key to managing risk and understanding how to use social media compliantly.
  • While we need to consider the different time zones of our audience, the latest data suggest Tuesday and Thursday mornings are good for sharing digital content. Releasing the same type of content on the same day provides consistency.
  • Catering for different learning or HCP types isn’t sophisticated enough. We need to combine different formats and modalities to support different learning styles, while also considering different demographics and digital competence.

Member research oral presentations

AI for the development of clinical trial lay summaries: are we ready to replace writers with machines?


KEY TAKEAWAY

  • Improvements are needed before AI can take over from writers in developing clinical trial lay summaries.

In the first of the three presentations in this session, David McMinn (Lay Summaries Ltd) shared findings from research into whether automatic text summarisation using natural language processing can accurately generate lay summaries. A literature search was performed to identify existing AI models, which were performance tested. The two best performing models were then fine-tuned and re-tested. McMinn found that the selected models were able to accurately produce certain sections of the lay summary, namely the title, background information, objective, and generic content but struggled with the results, adverse events, flow, and complex trial designs. The performance of AI models may be improved in the future with more powerful computers, larger data sets, enhanced metrics, and targeted text extraction. McMinn concluded that while AI does show promise, improvements are needed before writers can be replaced by machines.

Are conference presentations accessible? Insights from an online survey to improve equity


KEY TAKEAWAY

  • Less visual clutter on posters and providing slides ahead of talks would improve the accessibility of conference presentations.

James Wells (CMC Connect) presented results from a 23-question online survey, which was designed to establish accessibility requirements and preferred methods of receiving information among conference attendees with diverse needs. Of 493 respondents, 57% reported at least one accessibility need or disability, most frequently processing, sensory, hearing, or visual needs. Respondents preferred posters with less text, considering it easier to gain information from the #BetterPoster design than infographic examples or traditional text-heavy posters. When asked how posters could be improved, recommendations included:

  • less visual clutter (71%)
  • bigger text (48%)
  • bigger figures (43%)
  • plain language (42%)
  • audio summary via a QR code (32%).

Respondents felt it was easiest to gain information from talks with traditionally formatted slides containing text (with or without images), compared with TED-style talks with limited slides, slides with little text, or panel discussions with no slides. Recommendations to improve the accessibility of talks included:

  • providing slides ahead of the talk (66%)
  • recording a video of the talk for attendees to watch afterwards (60%)
  • more verbal explanations of images (50%)
  • bigger images (48%)
  • less text on slides (45%)
  • live closed captions (34%).

Respondents also provided recommendations for conference spaces, which included ensuring that there is sufficient seating (including in poster halls), ensuring sufficient space for wheelchair access, providing quiet spaces, improving acoustics/microphone use, and providing quality virtual options.

Respondents felt it was easiest to gain information from talks with traditionally formatted slides containing text (with or without images)…Recommendations to improve the accessibility of talks included providing slides ahead of the talk.

Adverse event reporting in industry sponsored primary clinical trial articles


KEY TAKEAWAY

  • A substantial proportion of industry-sponsored clinical trials articles use vague, general phrases to report adverse events.

In the final presentation of the session, Susan Wieting (Takeda) discussed the results of a study performed to assess how well the recommendation from Medical Publishing Insights and Practices (MPIP) to avoid overly general descriptions of adverse events (AEs) is followed in industry-sponsored clinical trial publications. A MEDLINE search was performed to identify abstracts of industry-sponsored peer reviewed articles (from the top 10 pharmaceutical companies by 2021 revenue) published in 2016–2022, that included one of the following phrases:

  • safe and well tolerated
  • AEs seen were minor and generally well tolerated
  • no unexpected AE
  • or a similar phrase.

In total, 103 articles were identified: 13 articles contained the phrase “safe and well tolerated” and 92 contained a similar phrase to those specified. Of these 92 articles, 49 used the phrase “well tolerated” and 24 included “generally well tolerated”. When assessed by year, the use of vague phrases had not reduced over time. Wieting noted that vague phrases are not informative, and highlighted the opportunity for the industry to consistently report specific AEs, which would increase the clarity and robustness of data.

Keynote: Global economic and policy influences on the pharmaceutical industry


KEY TAKEAWAY

  • Low–middle income countries are leading the way in healthcare innovations for an ageing population.

The Day 2 keynote presentation was given by Mark Chataway (Hyderus/Baird’s Communicant Management Consultants Ltd), who laid out the extent of the global challenges facing healthcare and what these might mean for medical communications.

An ageing global population

Chataway set the scene by charting the enormous changes in life expectancy seen over the last decade and forecast over the years ahead. In short, the world is getting older. Chataway outlined that life expectancy is generally higher in countries with greater levels of healthcare spending. He made the case that the additional cost can be offset to some degree by the spending patterns of older people, who will spend money rather than save it, thus giving back to the economy. This is augmented even further if ‘retired’ people also work part time, although Chataway noted that retirement ages haven’t yet kept pace with increased life expectancy.

What does this mean for medical communications?

  • Even more attention to measures such as quality-adjusted life years and disability-adjusted life years
  • increased focus on productivity gains and health-care resource utilisation associated with treatments
  • a need for better patient education on the quality of life possible in older age.

Health spending and system innovations

Another global trend Chataway highlighted was the decrease in extreme poverty. Despite this, health spending in low–middle income countries has not kept pace with increases in life expectancy. There are signs this is starting to change, as health sovereignty becomes more important in some regions and emerging economies look to invest in health technology. Examples include:

  • the G20’s focus on digital health innovations and solutions
  • the increased prevalence of innovative healthcare networks in some middle-income countries (eg in South Africa, nurse-led clinics refer through to leading institutions)
  • innovations capitalising on efficiencies of scale, as previously reported for heart surgery in India.

What does this mean for medical communications?

  • Some medical specialties are changing or even disappearing.
  • Publication professionals will need to support HCPs and researchers who are new to publishing.

As health sovereignty becomes more important in some regions and emerging economies look to invest in health technology…publication professionals will need to support HCPs and researchers who are new to publishing.

Personalised medicine

Chataway closed by noting the expansion of personalised medicine and related infrastructure, such as the large national health records database currently being established in India.

What does this mean for medical communications?

  • Registries and databases will become accessible to researchers in areas where cost may have been prohibitive until now.
  • Conversely, some of the largest new databases may place restrictions on what can be published.

GPP and me


KEY TAKEAWAY

  • GPP 2022 serves as expanded guidance to medical publications professionals and continues to evolve, yet authorship remains contentious and questions remain around the use of social media and AI.

The final panel discussion session looked at how GPP 2022, published in August 2022, has changed working practices for medical publications professionals. Moderated by Eleanor Raynsford (Ipsen), panellists were Laura Dormer (Becaris Publishing), Eline Hanekamp (Excerpta Medica), Fiona Plunkett (Articulate Science), and Vanderlinden. All panellists were GPP 2022 steering committee members and authors.

Ahead of the meeting, a questionnaire circulated via the ISMPP community forum and LinkedIn received 29 responses, with 59% reporting that the updates to GPP had affected their day-to-day activities. 75% of respondents still had questions about GPP 2022, aligning with three main topics: authorship, reimbursement, and patient involvement. These topics formed the basis of the panel discussion. The panel noted that the survey results were as expected, stating that “GPP 2022 is not a revolution.  It is an evolution, providing supplementary material to give everyday guidance.”

Authorship

GPP 2022 expanded guidance on authorship in line with ICMJE recommendations, including removing limits on the number of authors. The panel discussed that authorship should be considered on a case-by-case basis, and not subject to arbitrary limits. The panel noted that a steering committee should be established well in advance of publication initiation. The steering committee is then best placed to discuss any queries and concerns arising during publication development.

Authorship should be considered on a case-by-case basis, and not subject to arbitrary limits…The ISMPP Authorship Algorithm tool can help to determine author contributions to ICMJE criteria #1.

The ISMPP Authorship Algorithm tool can help to determine author contributions to ICMJE criteria #1 (substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work). Where large numbers of potential authors are involved, it is unlikely that all can contribute substantially to publication development. Assigning a study or working group would capture all individuals involved – these contributions are also indexed, for example on PubMed. Where appropriate, contributions should also be acknowledged and captured on indexing sites. The panel also discussed the case of individuals becoming unavailable during publication development, eg through parental leave or a new job. In this case, their role as author must be reassessed using the ICMJE criteria. A discussion should be held in advance of any known leave (ideally with the steering committee) on whether the individual will be able to fulfil their role. Sensitivities should be considered for leavers, for example those moving to competitors. Acknowledgement or contributorship may be suitable alternatives.

A case study was shared by Helen Chambers (Costello Medical), who noted that GPP 2022 had helped enforce good practice when discussing publication development processes with clients. Key to this was the guidance that all authors should be engaged prior to project initiation. Chambers reflected that ultimately, early author input drives a smoother process.

Reimbursement

GPP 2022 provides further details for reimbursement of HCPs and patients, the latter being a hot topic of discussion in other sessions. The panel noted that it is transparent, legitimate, and appropriate that a provider of services or a patient should receive payment for their contribution and still qualify as an author, as long as a full disclosure is incorporated. While authors cannot be paid for their name being listed as an author, it is possible to reimburse their time for contributing their expertise: patients should not be excluded as authors for receiving reimbursement for their services. However, company reimbursement policies for patient authors vary.

Tamzin Gristwood (Oxford Pharmagenesis) shared a case study where GPP 2022 provided clearer rationale around naming medical writers on review articles. Gristwood noted that if appropriate, the writer can be an author and also receive payment (through their professional medical writing role) in terms of time spent developing the article.

It is possible to reimburse [patient’s] time for contributing their expertise: patients should not be excluded as authors for receiving reimbursement for their services.

Patient involvement

GPP 2022 also provided guidance on working with patients, to ensure patient expertise is respected and assistance provided (if required) to help them reach their full potential for contributing as an author. GPP 2022 has increased the confidence of both agencies and pharmaceutical companies working with patients, providing guidance on how best to involve patients in the publications process. Importantly, patient author involvement must be meaningful and valid rather than a tick-box exercise, with early engagement ensuring that patient authors can be involved throughout the publication process. Patient authors and patient reviewer feedback are both invaluable, and provide a different perspective from that of HCPs.

Outstanding queries

Several areas of outstanding queries were also raised during the session.

In terms of patient involvement:

  • Although the development of PLS is becoming more common, is this medium providing patients with a voice if their involvement is limited?
  • Should journals question a lack of patient authors, and should they be looking to update their guidance on authorship?
  • Authors are generally required to provide details such as qualification, affiliation, and contact details. While a ‘traditional’ author can provide their work credentials, there is no clear guidance for patient authors.

In terms of social media:

  • There is clearly a need for guidance on social media, but GPP is not best placed to provide that guidance. Guidance would be best coming from a legislator or regulator.
  • Should authors work with publishers, so that journals share publications on social media?

In terms of AI:

  • While no information about the role of AI in publications was given in GPP, it was noted that the World Association of Medical Editors (WAME) and Nature both recently shared information that may serve as a useful reference point.

Poster awards, exhibitor raffles, and closing remarks

Rob Matheis (ISMPP President & CEO) and Raynsford closed proceedings, thanking the abstract review committee and poster presenters. This year’s poster prize winners were congratulated:

  • Most reflective of meeting theme: Why did it go viral? An informatics-based case study of exaggerated language in news and social media – Hollie Rawlings, Tomas Rees, Lubaina Koti, Avishek Pal, and Andrew Liew.
  • Best original research: Does publishing on medRxiv affect a manuscript’s outreach? – Pedro Caldas Custodio de Campos Silva, Christian Matheou, Alex Marshall, and Shilpa Khobragad.
  • Most innovative digital poster format or enhancement: Ghosts in the machine: retracted articles still haunt the literature – Stephen Craig and Andy Shepherd.

Why not also read our summary of Day 1 of the meeting?

The Publication Plan also looks forward to bringing you more insightful and thought-provoking coverage from the forthcoming 19th Annual Meeting of ISMPP, due to take place on 24–26 April 2023 in Washington, DC.

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Written as part of a Media Partnership between ISMPP and The Publication Plan by Aspire Scientific, an independent medical writing agency led by experienced editorial team members and supported by MSc- and/or PhD-educated writers.

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