Reconvening once again in Washington, DC, the 19th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) took place from 24-26 April with the theme ‘Patients First’.

With a record-breaking 720 participants, the meeting theme explored the role of patients and patient advocates as collaborators in medical research and medical communications. Thought-provoking and engaging keynote addresses, oral presentations, interactive sessions, and roundtables addressed these topics, plus other issues relevant to medical publication and communications professionals.

A summary of the afternoon sessions from 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.

You can also read our summaries from Day 1 , the morning of Day 2, and Day 3. 

Summaries of the afternoon of Day 2

Strategic scientific communication planning in an omnichannel world: everything you wanted to know but didn’t dare ask

KEY TAKEAWAYS

• For a medical affairs audience, effective omnichannel communication requires the right content, through the right channel, at the right time.

Omnichannel communication is increasingly being used in medical affairs, where there is an important need to clearly communicate complex information to a diverse audience. Michael Exon (Adelphi) and Dominic Sloane (Excerpta Medica) presented this introductory session on omnichannel communication in the context of strategic scientific communication planning, focusing on what omnichannel means for medical affairs and the key elements of an omnichannel plan.

What does omnichannel mean for medical affairs?

The presenters highlighted that omnichannel communication cannot be performed in isolation, but instead requires cross-functional collaboration using a structured approach to take a unified view of an audience’s information needs and preferences. Compliant sharing of audience data between teams is key to optimising omnichannel communication programmes.

Exon and Sloane explained that the healthcare professional (HCP) learning journey is inherently self-led, personal, and omnichannel; thus, there is no single model that can be imposed on all HCPs, and HCP learning journeys are unique to each individual. Accordingly, we must reassess our relationship with the HCP learning journey to create journeys that deliver “the right content through the right channel at the right time”.

There is no single model that can be imposed on all HCPs, and HCP learning journeys are unique to each individual.

What might an omnichannel medical communications plan look like?

An audience-centric approach dictates that the first step is to define and segment the audience. For example, is the HCP looking for top-level summaries, do they want to read in depth, or would they prefer to do their own research on a particular topic? With this knowledge, reusable, modular content can be developed to meet the needs of each audience segment, which can then be delivered through the relevant, connected channels. As a final step, content engagement with key audiences can be tracked and fed back into the initial segmentation to optimise the process and better define the audience segments.

The presenters highlighted the benefits of mapping the omnichannel approach, with the resulting interconnected framework divided into key channel types, namely third-party (eg, apps), owned (eg, publications, presentations, microsites, and emails), and earned media (eg, social media). While owned channels are easily updatable and provide valuable metrics thanks to everyday access, third-party channels can also host a level of controllable content and provide an element of trackable data, provided that functional partnerships are in place. Similarly, earned media is a worthwhile consideration as information communicated via this channel is inherently trackable.

How should I approach a data strategy for omnichannel communication?

As a first step, Exon and Sloane suggested liaising with internal stakeholders (eg, compliance, information technology, and other teams) to understand what is feasible and what is already being done within the business. The next step would then be to define what success might look like, establish metrics, measure impact, and receive feedback. In this way, it is possible to assess the effectiveness of engagement within each channel – ultimately, to ensure that communications work as well as possible and to permit the evolution and enrichment of content over time based on changing audience needs.

What does the future of omnichannel communication look like?

It is likely that omnichannel communications will focus on real-time personalisation of information enabled by modular content that is easily adaptable to local rules and regulations. This infers a key role for medical and publications teams in ensuring that all content ties back to scientific communications platforms and is supported by the current evidence base. As is increasingly the case, omnichannel platforms will feature mechanisms to facilitate constant improvement based on the data gathered. The presenters thought artificial intelligence (AI) and machine learning technologies will play an increasingly important role in transforming how individuals receive their information, via automation of insights, data analysis and content consistency, and generation of personalised content.

Artificial intelligence and machine learning technologies will play an increasingly important role in transforming how individuals receive their information.

ISMPP business meeting

KEY TAKEAWAY

• ISMPP approaches the exciting frontier of AI technology in a strong position to impact patient care through engagement with HCPs and patients as these new tools revolutionise the profession.

Outgoing Chair of the ISMPP Board of Trustees, Dan Bridges (Inizio Health), opened the business meeting with a review of the society’s finances, which remain robust despite the recent challenging economic climate. ISMPP President and CEO, Robert Matheis, then shared his outlook on the future for the medical publication profession. With the advent of new AI technologies, including ChatGPT, Matheis described the exciting prospect of being a medical publication professional with the ability to use these tools to make a measurable impact on patient care. Matheis also noted the influx of smaller biotechnology companies whose publication needs differ to those of larger firms but are met by the core skillset of medical publication professionals.

Reviewing the ISMPP strategy, Matheis explained that the focus on investment and evolution of the society to support geographical expansion, digital innovation, and growth of existing partnerships remains relevant today. On the horizon, Matheis outlined forthcoming changes to the ISMPP West meeting, which will transform to become the ISMPP Academy. In combination with a planned restructuring of the ISMPP Committees, as well as the shift to a 5-year cycle for the Certified Medical Publication Professional (CMPP) certification process, this change will allow ISMPP to remain nimble, current, and focused in its ability to address the needs of a new and wider membership base – now over 2,500 members – and the above-mentioned influx of smaller biotechnology companies.

AI technologies including ChatGPT present an exciting prospect for medical publication professionals to make a measurable impact on patient care.

Megan Weigel (Bristol Myers Squibb) delivered an update on the CMPP certification programme which has seen continued expansion into new territories, with new CMPPs in Sweden, Saudi Arabia, and Indonesia. Weigel encouraged existing CMPPs to become mentors to help others prepare for the examinations and reminded those in attendance of the 1 August 2023 application deadline for the next CMPP exam.

Bridges thanked departing members of the ISMPP Board of Trustees for their efforts during their 3-year terms and congratulated those newly elected to the Board, before handing over the gavel to incoming Chair, Monica Mody (Bristol Myers Squibb). In her closing address, Mody set out how the society will look to patients as guides to continue to publish data with rigour, transparency, and urgency and looked forward to the new frontier of AI technology while continuing to simplify information for HCPs and patients through initiatives such as enhanced publication content and plain language summaries (PLS) during her term.

Roundtables

On Day 2, attendees had the opportunity to take part in a second session of roundtables covering the following topics:

• Co-creating plain language content to ensure road reach and understanding
• Sharing real-world evidence with the public through plain language summaries
• The art of reaching the patient where they are: creating and disseminating valuable patient content
• Don’t be such a scientist! Unleash your inner storyteller
• Clear and present data: how to increase the impact and reach of your medical publications with effective and appropriate data visualization
• Local, regional, global publication plans – challenges to effective alignment
• Not better, not worse, just different: ethical publication practices in the Asia-Pacific region
• Beyond journal publication: boost your publication plan with extenders
• Copyright and licensing dos and don’ts
• Advocating the value of visually engaging posters
• Much ado about access
• An open forum for newer publication professionals
• ChatGPT and BardAI: the dawn of generative AI in medical communications
• ISMPP committees and opportunities for involvement
• Integration of artificial intelligence in medical communications for de novo content generation
• Creating consistent communication through effective scientific communication platform socialization
• Maximizing the value of an advisory board and steering committee meetings

Following the roundtables, attendees had the opportunity to attend parallel sessions.

Publication planning outside of the global setting – the need to embrace regional diversity to better support patients

KEY TAKEAWAYS

• To deliver the most impactful publications and greatest benefit to patients, it is crucial to engage with local publications/communications teams to understand cultural norms and requirements.

In the introduction and session overview, Blair Hesp (Kalnic Medical Communications) explained that English is the most commonly spoken language in the world. Yet, of the 1.5 billion people who speak English, three-quarters do so as a second language. This highlights the crucial need to be aware of cultural and linguistic diversity and emphasises the importance of understanding how diversity might influence publication planning and development practices. By combining local and international insights, it is possible to effectively optimise publication planning.

[There is a] need to be aware of cultural and linguistic diversity … … and how diversity might influence publication planning and development practices.

Semantics are important – geographical stratification can arbitrarily group heterogenous markets

William Dolben (Content Ed Net) discussed challenges to effective alignment in local, regional, and global publication plans. Given that more people are native speakers of Spanish and Mandarin, than English, it is important to consider the appropriateness of selecting the English language for publications. As publication professionals, we must be conscious of different cultures. As a case in point, Dolben highlighted differences between the English and Spanish languages and related cultural norms. For example, people in Spain have two surnames and these should be presented correctly in author lists. There are also inconsistencies in how terms are defined between the two languages, emphasising the importance of considering the accuracy and appropriateness of translations. This latter point is perhaps more important than ever, given the increasing need for translations as we move towards ever more patient-centric models of information delivery.

Obtaining comprehensive input from APAC-based authors will ultimately improve patient care

Jonathan Lee (Takeda Pharmaceuticals) presented author insights from the Asia–Pacific (APAC) region, stressing the need to consider cultural differences and communication preferences when engaging authors who speak English as a second language. In a cross-sectional survey of publication professionals, two-thirds of respondents noticed a qualitative difference in feedback from non-native English-speaking external authors, including a loss of context or clarity when providing feedback in English, and greater accuracy and detail when using their preferred non-English language. Lee concluded that forcing non-native English speakers to respond in English can be detrimental to the level of clinical insight gained, with potential follow-on repercussions for patients. Authors with English as a second language may also require more time to review, or access to appropriate translation support, to ensure relevant feedback. Lee went on to highlight the need to recognise cultural preferences and provided examples with reference to the APAC region. In a recent survey of publication professionals, two-thirds of respondents felt that in APAC, global publication guidelines are difficult to fully implement, require adaptation to accommodate the publication landscape, and do not consider cultural norms or practices.

In APAC, global publication guidelines are difficult to fully implement, require adaptation to accommodate the publication landscape, and do not consider cultural norms or practices.

Lee explained that societal or cultural traditions may place importance on consensus-seeking behaviours or on social hierarchy/seniority, whereby it is considered impolite or even rude to publicly challenge or question views held by those in senior positions. In these scenarios, one-to-one meetings, or emails, with the assurance that responses will be anonymised, may lead to more insightful feedback than group meetings or communications. To navigate these complex challenges, it is imperative that we engage with local publications teams to understand cultural norms and requirements. In doing so, we can obtain comprehensive local and regional insights to deliver relevant publications and improve patient care.

Mobilising patients as authors in publications

KEY TAKEAWAYS

• Patient authorship ensures that medical information includes a patients’ perspective and is digestible by non-medical audiences.
• Information for patients should be patient-integrated, not just patient-centric.

Jasmine Malone (OPEN Health) introduced and moderated this parallel session, which included short presentations by Elliot Abramowitz (Patient Advocate) and Imogen Allred (OPEN Health) and was followed by an extensive Q&A session.

Patient author perspective

Abramowitz – a published clinical psychologist with 40 years of experience – was diagnosed with stage 4 prostate cancer in 2013 and has been involved in patient advocacy since 2017. According to Abramowitz, medical information from the perspective of patients can only be conveyed by patients, with patient authors helping to make the information suitable for a non-medical audience. Providing a recently authored PLS published in Future Oncology, which was written by Abramowitz in collaboration with another patient author and an oncologist, Abramowitz explained how this type of collaboration can be helpful to all patients and foster patient–doctor dialogues.

Agency and publications perspective

Allred was an academic in neuroscience for almost a decade before moving into medical writing because she wanted to help patients in a more practical manner. She has worked across a wide range of therapy areas and types of materials for the last 3 years, including working directly with patients on review manuscripts and podcasts. In her view, patient authored publications should include the priorities of patients. Allred also thought it important to remember that patients are individuals and not a homogeneous group, with each patient having individual needs that must be considered. Allred emphasised the need to integrate patients in publication planning and ensure that the collaboration is mutually beneficial and empowers rather than targets the patient.

Patient authored publications should include the priorities of patients. Patients should be integrated into publication planning to ensure that the collaboration is mutually beneficial, empowering patients rather than targeting them.

The Q&A that followed these presentations highlighted the following key points:

• It is important to include patients as authors because medical publication professionals cannot incorporate patients’ perspective without their input.
• Although the ideal patient authors are those who are both patients and patient advocates, there is a need to include other patients’ viewpoints, as each patient is an individual.
• There is a lack of real consensus and guidelines on the processes involved for including patient authors.
• There is a need to make more patients aware of the potential to participate in publications.
• Some patients may prefer to participate in non-traditional types of communications such as videos, discussion panels, or podcasts.
• It may be beneficial to include patients as peer reviewers in publications.
• Many patients are uncomfortable with writing, so they need to be made aware that support with writing is available.

Developing a patient lexicon to enhance patient communication – a case study

KEY TAKEAWAYS

• Patient lexicons can reduce complexity and confusion in patient-facing materials, facilitating improved health literacy.

In this session sponsored by Vertex Pharmaceuticals, Reena Ketkar (Vertex), Ciara Silverman (Vertex), Alia Bucciarelli (Vertex), and Caroline Mathie (The Planning Shop) presented a case study on the development of patient lexicons in hemoglobinopathies.

Bucciarelli set the stage by emphasising the benefits of health literacy, explaining how low health literacy is associated with increased mortality, poorer self-reported health status, greater use of emergency healthcare services (but lower use of preventative services), higher rates of chronic diseases, and adoption of unhealthy behaviours such as smoking and alcohol consumption. Bucciarelli noted that improving health literacy was particularly important for rare diseases, where there can be less access to patient-facing materials compared with more common diseases.

Silverman went on to describe how a patient lexicon – a clear, accurate, and consistent vocabulary for a given disease state and/or therapy – can streamline communications with patients and caregivers and reduce complexity and confusion in patient-facing materials (including websites, consent forms, infographics, and PLS), thereby facilitating improved health literacy. Silverman outlined the key features of a patient lexicon as follows:

• Preferred term: the term that should be used to drive consistency and alignment.
• Definition: explanation of the term written at an appropriate level for patient communications.
• Non-preferred term(s):  terms that should be avoided to reduce complexity and confusion.
• Rationale: guidance and examples for how the preferred term and definition should be used.

The presenters then used a case study in the area of hemoglobinopathies to outline the process of developing a patient lexicon, from identifying and evaluating the pre-existing vocabulary used in a disease area/patient community; creating the draft lexicon and performing a health literacy review of its content; testing the lexicon with patients and caregivers and obtaining their feedback; and finally reviewing the feedback and incorporating it to develop and roll-out the final lexicon.

Ketkar concluded with some guidance on best practice for developing patient lexicons, highlighting the importance of including a health literacy section with the lexicon to improve accessibility and patient comprehension, and the need to incorporate sufficient time in the development process for appropriate medical, legal, and regulatory review. The presenters hope the lexicon presented in their case study (currently in its patient-testing stage) will help to standardise the language used to communicate with patients in the area of hemoglobinopathies and ultimately improve patient engagement and outcomes.

A patient lexicon – a clear, accurate, and consistent vocabulary for a given disease state and/or therapy –  can streamline communications with patients and caregivers.

Digital innovations in medical publications to enhance user experience and engagement

KEY TAKEAWAYS

• Digital innovations can address the current need to engage time-poor audiences and be compatible with the trend towards increased use of mobile devices for access to medical information.
• Immersive learning enables collection of unique insights and metrics that cannot be captured using non-digital or traditional methods.

The panellists for this parallel session on digital innovations in medical publications were Shalini Murthy (Parexel), Jennifer Granit (Parexel), Szilvia Mosolits (Bristol Myers Squibb), and Tara Miller (Bristol Myers Squibb). The focus of this session was to recognise key challenges for audience engagement in multiple settings and to identify innovative ways to engage with audiences, with the aim of improving the tools used for scientific exchange.

Audience engagement challenges

Granit summarised the current audience engagement challenges as the following:

• Information overload due to more journals, congresses, and podcasts/news being available for time-constrained HCPs.
• Limited engagement opportunities for HCPs due to hybrid and virtual congress formats.
• Difficulty in measuring impact beyond traditional citation analysis.

Revealing how polling of medical communications teams identified interactivity, visual representation of information, accessibility and engagement potential, brevity of information, and limited use of jargon as key components of digital innovation, Granit concluded that the ultimate goal of digital innovation is to increase retention and understanding of the content.

The ultimate goal of digital innovation is to increase retention and understanding of the content.

Granit expanded on two types of digital innovations: those that summarise or reimagine content to focus on key information and those that optimise format and features of existing content for better user experience. The former type of digital innovation includes digital publication enhancers such as infographics, videos, podcasts, animations, publication explainers, and graphical PLS. These require separate content development and processes to ensure scientific integrity. Conversely, the second type of digital innovations contains no or minimal new content and thus lowers the review burden on authors, as well as being less time-consuming.

A case study on immersive e-posters

Mosolits then presented results from a case study on an immersive e-poster version of an existing congress poster. The immersive e-poster tried to combine all of the features identified as top priorities for digital innovations: it was user-friendly (it automatically scaled to any device), allowed zoom and navigation, and captured insights/metrics (the interactive nature of the e-poster enabled users to provide their feedback by using sad/neutral/smiley faces to react to the content). The immersive poster was well received, with approximately 7 times more views than static PDF posters within the same category at the same congress and around 5 times more views than the static version of the same poster.

The immersive poster was well received, with approximately 7 times more views than static PDF posters within the same category at the same congress and around 5 times more views than the static version of the same poster.

Mosolits outlined potential challenges and considerations for developing the immersive poster:

• The need for new review and approval processes that ensured the HTML files were securely hosted and that the privacy of those who interacted with the poster was maintained.
• The need to balance legal and compliance considerations (to avoid leading questions and commercial feel or tone) versus content desired by authors and reviewers.
• Allowing the additional time needed to apply technology and approve interactive features.
• Ensuring all stakeholders were educated on how to use the features so they could present to colleagues and share the QR code and URL.
• Ensuring the congress was aware and supportive of the new features, particularly for the polling questions, because these were a novel feature of the poster.

Developing patient-accessible publication extenders: key stakeholder perspectives

KEY TAKEAWAYS

• Publishers should be aware of the variety of publication extenders that can accompany articles.
• Pharmaceutical companies should include PLS and other extenders at the earliest planning stages and consider developing style guides to ensure patient accessibility.
• Medical communications agencies can help ensure content is developed at a level appropriate for patient audiences and in an engaging format.
• Patient advocates are motivated to participate in content development and see value in furthering their understanding of their condition.

Caroline Halford (Springer Healthcare), Brian Scheckner (Jazz Pharmaceuticals), Jasmine Malone (OPEN Health), Jill Adelman (Patient Advocate), and Anna Frangou (session moderator, OPEN Health) formed the panel for this parallel session looking at developing publication extenders from a variety of perspectives.

The publisher perspective

Halford began by describing two established types of content and extenders:

• Materials for patients: eg, PLS, digital extenders (video abstracts, infographics, audio discussions), and PLS of publications (PLSPs)
• Materials by patients: eg, original research (PLS, videos), reviews (infographics, videos), commentaries (patient photos, audio slides), and podcast articles (infographics, plain-text transcript aids), where the target audience is not necessarily patients.

Halford referred to established data on the value of PLSPs for patients/caregivers as well as HCPs and explained how the metrics for patient authored content/extenders show they are impactful based on high numbers of downloads and citations.

The pharmaceutical company perspective

Scheckner then expanded on why pharmaceutical companies are interested in developing PLSPs, noting how they can align with the patient-centric mission and vision of pharmaceutical companies, allow patients and caregivers to seek further information about their disease state and treatments, and ensure that data are accessible to patients. Furthermore, open access PLS can increase diversity, equity, and inclusion by reaching all potential audiences. He reiterated that pharmaceutical companies can help to establish PLSPs as a standard part of the publication process by including them for all submissions and engaging with patient authors, reviewers, advocates, and/or caregivers where possible. The industry can also prioritise journals that peer review PLS and allow open access. Further, pharmaceutical companies can develop style guides for PLS creation (with appropriate reading levels and formats), as well as ensure budget allowances for PLS and other enhanced content.

Pharmaceutical companies can enable development of PLSPs by including them for all submissions, engaging with patient authors, reviewers, advocates, and/or caregivers where possible, and prioritising journals that peer review PLS and allow open access.

The agency perspective

Malone set out the agency perspective by asserting that everyone has the right to access and understand accurate information from reputable sources despite their background. She considered the following as key considerations for developing patient-accessible publication extenders:

• Do not presume to understand what patients want to read about – co-creation and validation are essential.
• Comprehension is key – follow the principles of health literacy.
• Ensure accessibility.
• Enhance engagement by employing engaging formats for information dissemination.

Malone then shared a step-by-step guideline for co-creating and validating patient materials starting with identifying the lay audience and their key unmet need. Once these are known, content should be developed emphasising the information most relevant to the audience and using visual and design elements where possible to aid understanding. Content should be reviewed for medical accuracy and to improve readability and comprehension, and Malone stressed the importance of the patient validation step to ensure the content is relevant, understandable, and meets the needs of patients. She added that smart use of creativity, technology, and tools can enhance the audience experience and improve data retention.

Smart use of creativity, technology, and tools can enhance the audience experience and improve data retention.

The patient advocate perspective

Finally, Adelman provided a patient perspective on publication extender development. She reaffirmed that patients need accessible materials to understand their disease, noting that inclusion of patient perspectives in publication extenders helps HCPs to truly understand the patient experience. Adelman shared that she was a patient author in an ophthalmology publication that was followed with a live podcast, and that participating in these activities made her feel that she was helping other people handle their own experiences better.

[Including] patient perspectives in publication extenders helps HCPs to truly understand the patient experience.

Guided poster tour: Plain Language Summary

On Day 2, the guided poster tour called out 4 posters covering the theme of Plain Language Summaries (presenting authors shown in bold):

• Who are the authors of plain language summaries of publications? – Catherine Elliott, Jacqui Oliver, Lauren Manning, Rachel Jenkins, Joanne Walker, and Dawn Lobban.
• Plain language summary formats: opinions and preferences of healthcare professionals – Caroline Halford, Matt Evans, Lydia Alborn, and Steve Winter.
• Achieving health equity through shared decision making: evolution of plain language summaries (PLS) – Brittany Wolf Gianares, Raj Patel, Shivali Shah, Jennifer Ghith, Sam Garas, Christan Thomas, Kristine Schuler, Dean Campbell, Luciano Passador, Leah LaRue, and Martina Schwarzkopf.
• Understanding the value of standalone plain language summaries of publications: updated findings from an online survey of readers – Jacqui Oliver, Dawn Lobban, Laura Dormer, Rachel Jenkins, and Joanne Walker.

 Awards reception

The 19^th Annual Meeting featured the inaugural ISMPP Professional Excellence Awards, with the society recognising the achievements of its members in the following categories:

• Lifetime Achievement Award: Yvonne Yarker
• President’s Award: Dawn Lobban
• Outstanding Committee Member Award: Sonia Schweers
• Rising Star Award: Simon Stones
• CMPP Award: Dana Fox

This year’s poster prize winners were also congratulated:

• Best Original Research: What do doctors really do on the internet? – Gary Burd, Nicole Strangman, Caitlin Schoensiegel, Shubham Sarcar, and Heather Figlar.
• Best Practice: A tale of three dashboards: the use of interactive data visualization in oncology publishing – Christian M. Thomas, Dean Campbell, Leah LaRue, Erikka Brewer, Travis Vaught, Julian Martins, Nishal Patel, and Jennifer Ghith.
• Best Visual Communications: Peer-reviewed research articles in non-traditional formats – hidden in plain sight? – Sara Black, Bjorn Hanger, Bakhouche Bakhouche, Clare Bellward, and Marc Swift.
• Publication Star: Are conference presentations accessible? Insights from an online survey to improve equity – Emily L. Messina, Zen Faulkes, Noofa Hannan, Mike Morrison, Anja Petersen, Heather Robertson, Lauren C. Strother, and James L. Wells.

Congratulations to all this year’s winners!

Why not also read the summaries of Day 1, the morning of Day 2, and Day 3 of the meeting?

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Written as part of a Media Partnership between ISMPP and The Publication Plan, by Aspire Scientific, a proudly independent medical writing and communications agency led by experienced and dedicated industry experts.

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The ISMPP Authorship Algorithm Tool is designed to help determine whether an author’s contributions are sufficiently substantial to meet the International Committee of Medical Journal Editors (ICMJE) Recommendations for Authorship. The  tool is now available and free for companies to use. To learn more watch the recent 90-minute ISMPP U webinar, which is available to both ISMPP members and non-members.

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Patient authorship is an important avenue on the road to patient centricity. A recent two-part series in The MAP Newsletter – written by medical communication professionals and patient authors – delves into three key questions surrounding patient authorship. Part A of the series answers the first of these: “What are the potential benefits for industry sponsors that encourage patient authorship and the potential risks for those that do not?”

In terms of publication plans and medical plans, increased real-world relevance and unity between patients and healthcare professionals are just some of benefits highlighted by the authors. Patient authorship could also improve sponsors’ relationships with patient communities, creating new opportunities within a sponsor’s own business or with important stakeholders. In the long term, the authors envisage a future of ethical and effective collaboration between patients, researchers and sponsors that do embrace patient authorship. Conversely, sponsors that do not pursue patient-focused innovation could miss opportunities for patient collaboration and may see their reputations on the line; patient communities could publicly criticise sponsors who exclude patient authors. As well as risking damage to their brands, these sponsors may encounter concomitant negative impacts on patient-dependent processes such as clinical trial recruitment.

The authors also explore the numerous factors that are driving patient authorship. These include increased availability of training for patients on how to author publications and implementation of strategies by peer-reviewed journals to promote patient authorship, such as the Patient and Public Partnership initiative adopted by The BMJ. The authors implore the whole publication community to consider their stance on patient authorship, and suggest that medical publication professionals are in a position to optimise the patient authorship experience for all involved.

In Part B of this two-part article authors share practical advice, addressing the questions, “How can patient authors meet the first ICMJE criterion?” and “What challenges might patients face when becoming authors and how could medical communication professionals help address these challenges?” Look out for our summary, coming soon!

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Summary by Emma Prest PhD from Aspire Scientific

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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd

The 2019 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 22–23 January and attracted more than 300 delegates; the highest number of attendees to date. The meeting’s theme was ‘Scientific Communications in a Fast-Paced World: Fighting Fit for the Future’ and the agenda focused on innovations in data publishing, open access, patient involvement in publications, and the expanding role of the publication professional. Industry newcomers had the opportunity to attend a satellite training session and all delegates were treated to two keynote addresses, lively panel discussions, interactive roundtables and parallel sessions. Delegates also had the chance to present their own research in a poster session.

A summary of the second day of the meeting is provided below for those who could not attend. A summary of the first day of the meeting can be found here.

Early rise evidence boot camp

In one of three parallel sessions, Richard Macaulay (PAREXEL) discussed how the use of real world evidence is beginning to change regulatory procedures, allowing certain therapies to be approved at an earlier stage of the drug development process. Macaulay highlighted the different requirements needed from a payer’s (ie to reimburse) or regulatory perspective (ie to approve a drug). While a regulatory agency’s decision to approve is largely based on efficacy and safety in randomised clinical trials, the payer also requires evidence that it is cost effective. Payers also want to see evidence that a new therapy provides a benefit over the current standard of care, but demonstrating this can be challenging. For example, a greater number of patients may be required to power a trial to show superiority over an active control, compared with placebo. Therefore, other strategies that leverage real world evidence are being employed. For example, real world evidence from early access programmes may be utilised in submissions. Under one such programme, the Early Access to Medicines Scheme (EAMS), patients in the UK can access treatments that have not yet received marketing approval, if there is a clear unmet medical need. Payers are also developing alternative ways to approve drugs, such as a temporary period of reimbursement, during which time real world evidence can be generated to support full approval. The Cancer Drugs Fund, for example, provides interim funding for cancer drugs in England, until sufficient data can be collected for routine commissioning. Another strategy that payers may consider is linking reimbursement to real world outcomes through performance-based pricing. Macaulay advised that companies not only develop processes to generate real world evidence, but also consider how such information should be optimally disseminated when designing publication plans.

In the second half of the session, Matthew Booth (PAREXEL), on behalf of Melinda Daumont (Bristol Myers Squibb), discussed I-O Optimise, a collaborative initiative, that aims to generate scientific insights based on real world data within the areas of non-small cell lung cancer, small cell lung cancer and mesothelioma. The programme consists of three phases covering pre-launch, early post-launch and established treatment use for each indication. Indication-specific protocols have been standardised to enable the cross-evaluation of complementary real world data from geographically diverse regions. Collaboration is instrumental to the success of the initiative. An External Scientific Committee has a key advisory role, guiding agenda and strategy, while a cross-functional core team comprising clinical, development, commercial, and publication leads, meet regularly to provide ongoing feedback. It was noted that dealing with such large datasets presents certain challenges, such as prioritising publication of the data. Another potential issue is how to accommodate delays with data availability while ensuring the timely publication of results. A further consideration is the extent to which different information needs to be conveyed for each indication versus the need to publish unified information for all. To overcome these potential difficulties, it was recommended that publication plans are in place before data are analysed, and are reviewed and updated regularly.

Innovations in data publishing: hitting the ground running, and making each step count

A second parallel session was moderated by Jan Seal-Roberts (Adis, Springer Healthcare) and examined recent trends in data publishing and data engagement through innovation.

Caroline Halford (Adis, Springer Healthcare) began by highlighting that recent key trends in publication planning seem to be focused on presubmission, production, and post-publication initiatives to increase speed, agility and impact. For example, more authors are starting to look beyond impact factor when considering which science, technology & medicine journals to submit their publications to. A recent survey of over 30,000 authors conducted by Springer Nature revealed several key factors driving journal choice, including reputation of journal, readership and reach, speed of publication, and open access availability. Halford illustrated this point with the Springer Healthcare journal Infectious Diseases & Therapy, which does not have an impact factor but is PubMed indexed and open access. Compared with the flagship Springer Healthcare journal Advances in Therapy, Infectious Diseases & Therapy has a higher acceptance rate, and similar citation and readership rates. Another recent trend is that more authors are choosing the rapid publication options now offered by an increasing number of journals.

Halford moved on to provide some tips to ensure a successful publication. Common reasons for a manuscript to be rejected by a journal include poor English/grammar, confusing/unclear structure, and unclear methodology. Many healthcare professionals have limited time so clarity — particularly within the title and abstract of the article — is key. Several tools are available to help increase the clarity of a manuscript; for example, visual abstracts and plain language summaries can aid understanding for patients, non-specialists, or members of the public. If a trial is particularly complicated, publication of a protocol/trial in progress article could aid understanding before the primary data are reported. The use of digital additions to publications are on the increase with many journals offering cascade initiatives (such as video abstracts, educational videos, slide sets, video articles, surgical/practical videos, audioslides, animations, infographics, and podcasts).

Halford ended her talk by noting that an increasing number of authors are now sharing their research on social media. Some top tips for social media success include: linking with hashtags for conferences, world disease days and disease (where appropriate); tagging author affiliations; sharing on affiliation pages; authors cross-posting (retweeting).

Anne-Clare Wadsworth (Envision Pharma Group) went on to discuss data engagement through innovation. As a starting point, Wadsworth emphasised that medical congresses remain a focal point for healthcare professionals in their medical education journey, but noted that there is an increasing expectation that meeting materials will be available online. As such, medical societies are adopting innovative approaches during their events to aid engagement. Wadsworth illustrated her point with a case study of digital content engagement at the annual European Association for the Study of Diabetes meeting, noting that online viewings of 14 recorded presentations reporting data from phase III studies were equivalent to 10–50% of the physical attendees. In addition, third-party sources are building content platforms featuring data from medical congresses; for example, ecancertv hosts video interviews from the key international oncology congresses including those of the American Society of Clinical Oncology and the European Cancer Organisation. Moving away from traditional methods for circulating data (detail aids, conferences, journals), multiple touchpoints are now available to healthcare professionals which are changing the way they access content, such as: infographics, eJournals, eForums, portals, social networks, instant messaging, eLearning, eDetails, mobile apps, and blogs. However, it is important to note that, despite technological advances and changing habits, long-form content is still popular, with in-depth articles being shared the most on social media.

Wadsworth discussed the various ways in which presentations can be enhanced to speed up access, augment understanding and increase engagement, through the use of audio visual additions, mobile-friendly content and infographics. An online survey conducted by Envision Pharma Group in December 2018 suggests that readers are starting to engage by accessing enhanced content at congresses or additional content via QR codes and results of a recent ISMPP members’ poll revealed that 51.2% of responders (n=207) plan to use digital enhancements in 2019.

As well as the evolution of audience engagement at congresses, Wadsworth noted that the patient perspective is becoming increasingly important to consider. Patients will occasionally attend a medical congress to raise awareness of treatment developments via social media; for example, Julie Flygare blogged about her attendance at the 2018 SLEEP meeting to raise awareness of treatment developments for narcolepsy. Moreover, Wadsworth highlighted that plain language summaries can enhance science communication; not only for trial participants and patients seeking scientific information, but also for managers/decision makers, and scientists (both within and outside the field of research).

Leveraging medical data – ways to maximize impact for the long run

In a third parallel session, Theodora Bloom (The BMJ) spoke about preprints and open peer review. Preprint servers have been around since the early 1990s starting with the physics platform arXiv, followed by bioRxiv for biology research and soon to be joined by MedRxiv for medical research. These sites offer a platform for researchers to deposit non-peer reviewed manuscripts in return for a citable digital object identifier number. The BMJ supports the use of preprint servers prior to publication, recognising their importance in speeding up citability and access to medical research. In response to audience concerns around posting non-peer-reviewed information, Bloom highlighted the importance of clearly marking preprints as preliminary findings, and further explained how additional safeguards in the screening process at bioRxiv means an article is not posted if doing so is considered to put public health at risk.

Bloom then spoke about The BMJ’s commitment to fully open peer review, in terms of both identity and comments. Open peer review has been shown to improve the quality of comments received and decrease the rate of rejection without affecting the time taken for review. Critically, although slightly more peer reviewers need to be invited to complete reviews, the initiative has mostly been well received by the scientific community. Bloom also stated support for post-publication peer review through comment posting, although recommends that responses are moderated.

Richard Ashdown (Caudex Medical) and Simon Fry (Springer Healthcare) then presented a more abstract concept to reform the medical publishing industry. The majority of the audience were already at least partly familiar with Bitcoin, which intends to disrupt traditional financial systems through its decentralised digital currency. Ashdown and Fry propose that the blockchain principle underlying Bitcoin could solve issues in the ‘data ecosystem’ such as data ownership, identifying source data and tracking the processing of data. Under the blockchain principle, data generated from research would be held in a decentralised digital database or ‘ledger’, where any modifications/usage of the data would be trackable, and control of the data would be ‘democratised’. Under this new spirit of verifiable data processing, public perception and trust in publishing brands would be a key factor for successful journals, underpinned by transparent processes such as open peer review. Interestingly, the ‘openness’ of the science blockchain could be variable, allowing certain users different access rights. One exciting envisaged outcome is that patients could control their own health data and how it is used. On the Gartner Hype Cycle, which tracks new technologies with the potential to transform human lives, blockchain is currently descending from the ‘peak of inflated expectations’ into the ‘trough of disillusionment’. Nevertheless, as blockchain gains traction in other areas, such as the music industry, Ashdown and Fry may well be forecasting the next revolution in medical research.

Maintaining our core strength: driving publication integrity through leadership

Gavin Sharrock (Wiley) introduced the panel session by describing how publication ethics has become a major focus for the publishing industry over the last 25 years. Advances have included the formation of the Committee on Publication Ethics (COPE), the development of authorship guidelines, such as the Good Publication Practice (GPP3) guideline, and global congresses held on the topic. Sharrock introduced the panellists who described the integrity issues they face in the world of medical publishing.

The author perspective came from Edwin Gale (University of Bristol) whose long career as a researcher has seen the replacement of ’eminence-based medicine’, where the treatment a patient receives is primarily driven by the physician’s own clinical experience, with evidence-based medicine and the emergence of randomised controlled trials as the gold standard in clinical research. Gale’s opinion was that market-based medicine is now an additional factor. He argued that companies perform and publish results from clinical studies to provide evidence for product approval, but that this leaves evidence gaps and unanswered questions once the product has launched.

Robert Wright (Sanofi) then spoke from the pharmaceutical industry perspective, noting that pharmaceutical companies have always been under a great degree of scrutiny regarding how they carry out and report the clinical studies they sponsor. He highlighted that this scrutiny has driven the industry to take massive strides over the last two decades to meet the escalating demands for clinical trial transparency and data and information sharing. Voluntary adoption of ‘Principles for responsible clinical trial data sharing’ from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) and improvements in company systems and processes, such as the introduction of corporate integrity agreements, has meant that pharmaceutical companies are now amongst the most compliant with reporting standards. With regards to the future of open access, Wright believes that there is general agreement across the industry that “knocking down the paywall” is a good thing for both healthcare professionals and patients, but questions remain about how this can be broadly implemented.

Next up, Simon Stones (patient advocate and consultant) shared his views on publication integrity from the patient perspective. Stones stated that while we carry out research to improve the lives of patients, this fact is frequently forgotten when it comes to communicating the outcomes of research. Patients are often keen to learn about their condition and potential treatments, but many say it is hard to find accessible, credible and accurate information. While there are some journals that have the patient audience in mind, and the use of plain language summaries is becoming more popular, Stones concluded that there is still more that can be done to engage patients.

Matt Hodgkinson (Hindawi) then provided an overview of the ways in which publishers maintain publication integrity and the associated challenges. These challenges include misconceptions around declaring conflicts of interest. Hodgkinson highlighted that conflicts of interest are not just financial conflicts, but can relate to anything that might affect how the research was done or reported and should not be considered an admission of bias. The increased use of reporting guidelines has benefited medical publishing, but Hodgkinson noted that this has brought about a ‘tick-box mentality’ which authors need to move beyond. Requirements for data sharing statements within papers are also becoming more common but Hodgkinson suggested that requests for data are not always accepted and monitoring this is not straightforward. Confusion remains regarding what data needs to be made available for sharing and exactly whose responsibility it is. Hodgkinson also highlighted several authorship integrity challenges for publishers, such as verifying author identities and who qualifies as a legitimate author. Lastly, he remarked that questionable or ‘predatory’ publishers are also still a problem and advised researchers to think, check, submit to identify trusted journals.

Finally, Gordon Muir-Jones (Porterhouse Medical US; ISMPP Ethics and Standards Committee) described the leadership role ISMPP has taken in driving and ensuring integrity in medical publishing. Muir-Jones began by giving a brief history of ISMPP and explained how the vision and mission of the society has evolved since it was formed in 2005. He also highlighted the many initiatives that ISMPP has introduced, such as ISMPP University, the CMPP certification program and the mentoring scheme, and indicated that more developments are on the horizon. While the session highlighted the amount of work required to maintain publication integrity, Muir-Jones concluded on a positive note declaring that it was an achievable aim, especially when stakeholders collaborate, and it is tackled one step at a time.

Speed work: research presentations

The number of poster presentations by ISMPP members continued to rise this . The meeting abstract committee, chaired by Laura McGovern (Nucleus Global), selected three of the best abstracts for oral presentation during a ‘Speedwork’ session at this year’s meeting.

Heather Lang (Oxford Pharmagenesis) kicked off the first, preprint-focused presentation with the statement that “preprint servers are definitely here, and they’re here to stay”. In order to address the question ‘Is pharmaceutical industry research posted as preprints?’, the group searched the bioRxiv biology preprint server for authors affiliated with the top 50 pharmaceutical companies. They found that half of these companies have published preprints, with corresponding authors from 10 of the top 50 companies. The majority of these preprints reported basic research. Although most preprints were not commented on or revised, the team found this seemed to be the norm for preprints uploaded to bioRxiv. Importantly, two-thirds of preprints posted for at least a year had subsequently been published in a peer reviewed journal. Lang concluded with a number of suggestions for the pharmaceutical industry: 1) To evaluate which types of research are appropriate for preprints; 2) To consider running pilots to explore the use of preprint servers; 3) To develop and communicate policies on appropriate use.

Next up, Caroline Shepherd (CMC) reported her team’s work on the ‘Evaluation of plain-language summaries (PLS): Optimising readability and format’. Selected for this study were three articles published in top-tier journals between May 2016–May 2018, reporting on phase III randomised controlled trials in one of three indications (psoriasis, multiple sclerosis [MS] or rheumatoid arthritis [RA]). Four plain language summaries were developed for each article: one in infographic format and three written with a low, medium or high degree of complexity. These plain language summaries for psoriasis, MS and RA were then disseminated to patient groups alongside a 20-question online survey. Shepherd highlighted the unexpected finding that, of 167 respondents, approximately half held a higher education degree; a population that Shepherd postulated may better represent individuals likely to seek out and read plain language summaries. Across all three indications, weighted-average preference scores demonstrated infographics and medium-complexity (reading age 14–17 years) text plain language summaries to be the first and second most popular first-choice preferences, respectively. Shepherd advised that these preferences be accounted for when preparing plain language summaries to accompany original research articles, and shared some recommendations for their preparation. For infographic plain language summaries, these included effective and consistent use of colours, layout and icons, and an overall focus on the ‘so what?’. For text-based plain language summaries, tips included the use of short sentences and readability scores.

The session drew to a close with a presentation from Anisha Mehra (Cello Health Communications) on her team’s ‘Evaluation of data reporting in real-world publications in clinical versus health economic journals’. This study aimed to decipher trends in RWD publication across four therapeutic areas, and to assess the quality of data reporting according to International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations. Literature searches were performed using PubMed for real world datasets on diabetes, psoriatic arthritis, haemophilia and wet macular degeneration published in the top five therapeutic area-specific clinical and health economics journals between 2015–2017. Those in psoriatic arthritis were selected for a more in-depth analysis using the ISPOR retrospective database checklist. The team found that real world data were commonly published in clinical journals; a total of 1,003 and 75 articles reported real world data in clinical and health economics journals, respectively. In data quality analyses, health economics journals appeared to more consistently publish articles adhering to ISPOR checklist criteria compared with clinical journals. Mehra suggested this may reflect a lack of awareness of good reporting guidelines for these types of studies in journals outside of the health economic community, and concluded that consistent and transparent reporting in real world publications will require ongoing efforts from authors and journals.

Keynote: no more robowars

In day 2’s keynote address, Simon Fry (Springer Healthcare) discussed artificial intelligence (AI) and its potential role in healthcare and medical publishing. Fry noted that a wide spectrum of views exists with respect to the potential benefits and downsides to the increasing prevalence of AI and referred to futurist Raymond Kurzweil’s prediction that the rate of change in technology will occur at an exponential rate, with machine intelligence surpassing that of humans within decades.

In the past, the progress of AI was limited by an inability to amass sufficient computer power to carry out particular tasks. However, this issue has now largely been solved, leading to an explosion of AI use across many different fields. Several examples exist within healthcare of AI being used to complement and enhance human expertise. Microsoft’s Project InnerEye uses AI for radiological imaging and precision surgery. The surgery is driven by humans, but its accuracy is improved through the utilisation of AI. In this way humans and machines work together, to achieve optimal results. IBM’s Watson Oncology, is a question-answering computer system, designed to support physicians with cancer care decisions. The system, which can analyse vast quantities of RWD, was trained by physicians from Memorial Sloan Kettering to interpret clinical information from cancer patients and determine individualised treatment recommendations. In this example AI is used to assist clinicians with evidence-based decision making. Deontics is another example of an AI-powered tool designed to support clinicians with decision making. AI is also being used within medical publishing. Synchrogenix, a consultancy of regulatory and medical writers, reports the ability to generate 80% of the first draft of a regulatory document such as a clinical study report within 24 hours, using AI, based on documents such as a study protocol and statistical analysis plan.

While machines may be able to take over data-driven tasks, Fry argued that healthcare requires human delivery. He suggested that increased use of technology may raise the value of processes that cannot be automated, such as doctor–patient interactions. Fry also noted that the increasing use of AI is likely to raise a number of legal, emotional, socioeconomic and financial questions.

Staying ahead of the game: news, views & controversies

In a world where Kim Kardashian, with her 59.5M Twitter followers arguably has more influence than, the Editor in Chief of The BMJ (who has 12.6K), how do we address the challenge of health-related ‘fake news’? This was the intriguing question at the beginning of a fascinating session moderated by Andy Powrie-Smith (EFPIA), with a panel comprising Theodora Bloom (The BMJ); Dhruv Ghulati (Factmata), Nicole Rapior (Boehringer Ingelheim), Stuart Spencer (The Lancet), and Chris Winchester (Oxford PharmaGenesis; Chair, ISMPP Board of Trustees).

The first step in addressing the challenge of health-related ‘fake news’ is identifying where inaccuracies in reporting arise. The panel felt that press releases from the pharmaceutical industry and respected journals are generally balanced but that inaccuracies are frequently introduced once news has been translated for mainstream audiences; journalists frequently over-simplify scientific findings in their desire for an attention-grabbing headline. Bloom noted that The BMJ highlights potential limitations of research in its press releases to help journalists to contextualise news; Spencer felt that the industry could go further by including ‘downsides’ in press releases – for example, information about potential adverse events and reproducibility of results. Ghulati noted that social media presents a particular problem as the small fragments of information presented often have no context.

Powrie-Smith asked the panel to think of one way to fight ‘fake news’ in healthcare. Winchester, from the medical communications standpoint, suggested that anyone should be able to access high-quality information so open access should be mandatory for pharmaceutical industry-funded research. Rapior felt that the industry should think more broadly in terms of the potential audiences for medical publications. From the publisher’s perspective, Spencer proposed that balanced summaries and narrative meta analyses would help, while Bloom’s view was that, firstly, every press release should state how long it would be until the drug/technology would be available to patients, and secondly, that post-trial surveillance should be routine to ensure that information is updated as new evidence becomes available. Ghulati had the last word from the panel and felt strongly about the need for individual scientists and researchers to be involved in scientific communication, checking claims and evidence and involving the public. “You’re trusted as a scientist: do your job”, he urged.

After a successful and thought-provoking 2 days the 2019 European meeting of ISMPP drew to a close, with Al Weigel (ISMPP President/Chief Operating Officer) thanking delegates, the meeting faculty, the Programme Committee, and the meeting sponsors and exhibitors. Presentations will be posted to the ISMPP European Meeting Archive in due course.

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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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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd

The meeting began with a series of pre-conference workshops before being formally opened by a welcome address from outgoing Chair of ISMPP Board of Trustees, Juliana Clark (Amgen). Clark introduced the theme of this year’s meeting, ‘From Publication to Practice: Advancing Science Through Effective Communication’, which focused on the evolving role of the publication professional, the importance of effective communication, and emerging trends within the medical publications industry. These topics were explored through keynote addresses, lively panel discussions, and interactive roundtables. As in previous years, members were also given the opportunity to share their own research via oral and poster sessions. The meeting was attended by both highly experienced professionals and relative newcomers to the industry.

A summary of the first half of the meeting (Monday and Tuesday morning) is provided below for those who could not attend, and as a timely reminder of the highlights for those who did. Many of the presented slides and posters are available to ISMPP members here. A summary of the second half of the meeting is available here.

Keynote address: beyond disclosure – working toward better outcomes for patients

In the first of three keynote presentations at the meeting, Olivia Shopshear (Pharmaceutical Research and Manufacturers of America [PhRMA]) spoke about data sharing and transparency, a topic that was also discussed at the 2017 Annual Meeting. Expanding on last year’s discussions, Shopshear focused on how meaningful changes could be implemented in clinical practice to lead to an improvement in patient care. Key events resulting from an increased drive for greater data transparency were presented, from the requirement to register all clinical trials outlined by the International Committee of Medical Journal Editors (ICMJE) in 2005, to the Principles for Responsible Clinical Trial Data Sharing published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in early 2018. It was noted that there is a current emphasis on making more data available rather than on how to responsibly utilise data.

Shopshear continued by noting that biopharmaceutical companies have been criticised for a lack of clinical data transparency. However, according to a report published by the IFPMA & PhRMA in November 2017, 98% of their 44 member companies were sharing clinical trial data above and beyond legal and regulatory requirements. Findings from the survey also showed that 64% of member companies had received requests for access to data, and that 64% of requests were for patient-level data. The majority (80%) of requests had been approved. Reasons for requests being denied included: data sharing not being covered by the informed consent for the trial; researchers failing to include a research proposal with their request/submitting incomplete applications; and data that could not be sufficiently anonymised.

Despite a large number of requests for data, the overall use of data-sharing platforms has been limited to date and the number of publications resulting from such requests is low. Several non-profit funder initiatives are being implemented with a view to increase data sharing among the medical research community. In addition, regulators such as the FDA, the European Medicines Agency and Health Canada have implemented policies regarding clinical data transparency. However, as highlighted by Shopshear, maintaining shared data while ensuring patient privacy is a challenge.

Shopshear went on to discuss how benefits associated with data sharing can lead to better outcomes for the patient. Increased engagement from both healthcare professionals and academic researchers was considered crucial. Other developments that may potentially lead to improved patient care include: a requirement for lay summaries in the US (similar to that adopted in the EU); improved interoperability of existing data sharing platforms; and a ‘watchdog’ system to measure the impact of data sharing in a clinical setting. Shopshear concluded that the sharing of clinical data will benefit clinicians, researchers, biopharmaceutical companies and patients. However, data must be shared responsibly and, crucially, patient privacy must be maintained.

A new wave of patient privacy measures: the General Data Protection Regulation (GDPR)

With the General Data Protection Regulation (GDPR) due to come into effect later this month, Jordan Louise Fischer (XPAN Law Group and Drexel University) gave a very timely presentation on the relevance of GDPR to patient privacy. Fischer began the discussion by asking the audience whether they had heard of the GDPR. Of the 471 audience members who responded, 73 (15%) believed that they had a good understanding of GDPR, 184 (39%) stated that they were ‘only familiar with the general concept’ and 214 (45%) had not heard of GDPR.

GDPR, which was first announced 2 years ago, will take effect on 25 May 2018 and will apply to the processing of personal data related to a EU natural person. It was noted that the definition of personal data is deliberately broad, as is the term ‘processing’ which encompasses the storage, collection and analysis of information. The new regulations will not only cover data collected from 25 May onwards, but also existing data already on file.

Non-compliance with the new regulations will incur penalties of 4% of global revenue or €20 million (whichever is higher). Fischer highlighted that liability will be dependent on an entity’s role in the processing of data, with ‘controllers’ being those ultimately responsible and ‘processors’ having secondary responsibility.

Although GDPR does not apply in the US, US-based companies collecting data from individuals within the EU will need to comply with the new regulations, regardless of where the data are stored. Further, although an individual has the right to request that their data are deleted, the technicalities of doing so can be a challenge.

GDPR applies to the processing of personal data for scientific research purposes and publications, so has a direct relevance to the medical communications industry. With GDPR coming into effect in a matter of days, Fischer advised the audience to know their data, systems and partners/vendors in preparation for these impending new measures.

Patient engagement and involvement in medical publications: how much and how far?

In this panel discussion Steven Rizk (Genentech), Bill Silberg (Patient-Centered Outcomes Research Institute [PCORI]), Beverley Yamamoto (Hereditary Angioedema, International) and Moderator, Karen Woolley (Envision Pharma Group), shared their views on how and why patients should be involved in the entire medical research process, including publications.

Woolley began with an overview of guidelines that reflect the importance of patients (eg from IFPMA, ICMJE) and advocate patient engagement in medical research (eg from PCORI). She also highlighted that as ‘persons with expertise in the therapeutic area’, the Good Publication Practice guidelines (GPP3) allow for patients to be involved in publication steering committees and that ICMJE does not prevent patients from being authors on publications.

The panel went on to discuss the benefits of engaging patients, noting that their participation can lead to more focused questions being addressed by clinical trials and more patient-centric publications. The panel then suggested ways in which publication professionals could involve patients, advising attendees to ask their clients whether patients have been included in publication steering committees, and to be aware of the EU regulation regarding lay summaries. Yamamoto felt that the inclusion of patients should be a requirement for funding requests, to demonstrate the pharmaceutical industry’s commitment to the involvement of patients from the outset.

The view that patients should have a more active role in publications was overwhelmingly shared with audience members, with most agreeing that a section on patient engagement should be included in GPP4. Woolley rounded off the presentation, by urging medical professionals to more actively reach out to patients, stating that the “time to change is now”.

Following this presentation and a coffee break, delegates had the opportunity to attend two of five parallel sessions, four of which are summarised below. The fifth parallel session was a guided poster tour that featured three delegate posters on the topic of ‘patient engagement’.

Scientific platforms 101: introduction to scientific communication platform development – a cross-functional approach

In one of four parallel sessions, Jamie Kistler (CHC Group) described how to successfully develop and implement a scientific communication platform (SCP). Kistler explained that the SCP “provides a strategic foundation for a product’s medical communication plan” and should be a continually evolving document, which is developed by a cross-functional team. Kistler outlined and shared examples of the key elements of a SCP:

• scientific pillars: key communication themes that help to prioritise the overall story flow
• communication objectives: highest-priority objectives for communication of disease state information and product attributes
• core scientific statements: high-level, standardised statements used to describe the disease state and product
• supporting statements: detailed statements linked to specific supporting references or data sources
• lexicon: clear, accurate and uniform vocabulary supporting the disease state and product.

The SCP should be based on scientific and clinically relevant evidence, taking into account internal factors relating to the product itself and the external environment, such as competitor products and stakeholder perceptions. Kistler noted that there may be global or regional differences with regards to factors such as reimbursement, regulatory bodies, patient groups and treatment guidelines. The SCP is likely to be rolled out to a large group of users and impact a wide range of activities spanning publications, public relations, medical affairs and regulatory information. Finally, the audience were presented with a series of case studies demonstrating how SCPs can be effectively used in practice.

Scientific platforms 201: successful implementation of a scientific communication platform

Building on the Scientific Platform 101 session in which Jamie Kistler (CHC Group) discussed the development and implementation of a SCP, in this session Todd Parker (MedThink SciCom), Noella Vang (Amgen) and Kistler focused on broader considerations related to a SCP.

Parker began by highlighting that training the wider team is critical to the successful implementation of a SCP. The process should involve the identification of key stakeholders and selecting the optimal training format (such as online training modules). The uptake and use of a SCP can be monitored through usage metrics across document types, gap analyses and, for training administered online, web metrics such as page visits and resources downloaded.

Vang continued by describing how the supporting statements and lexicon in the SCP should be used in other project types and activities. These include publications, congress presentations and booth activity, symposia, websites, mode of action videos, training materials, regulatory documents, medical information/FAQs and press releases. Case studies were shown on how the consistency of implementation of the SCP could be tested.

Kistler concluded the session by presenting a case study of the successful development and implementation of a franchise-level SCP. Elements of best practice included holding a cross-functional workshop that included senior leaders, producing a short and interactive PDF that accompanied the full SCP to increase accessibility, and conducting SCP training before key meetings. The measure of success was immediate internal and external uptake of the SCP.

Best practices in video abstracts

Michele Avissar-Whiting (Research Square) provided an overview of video abstracts, best practice tips, and their benefits. Citing examples of how the results of scientific publications can be misrepresented in the lay press, Avissar-Whiting suggested this disconnect may start with the publication itself, which is often full of jargon and scientific terminology. Video abstracts are a way of communicating complex scientific ideas and concepts in a more accessible fashion.

Video abstracts are often in ‘talking head’ format (‘blog’-style, filmed using free software such as Wistia, Camtasia or Spark, or professionally filmed); animated and infographic-style videos are also popular. ‘Talking head’ videos have a more personal feel, and selecting a dynamic speaker is recommended. Animation videos are engaging and are better suited to illustrate certain concepts, but the human touch is lost. Avissar-Whiting recommended that a video abstract should have a link to the primary manuscript and be:

• accessible: plain language, 2–4 minutes in length
• clear: clearly state purpose, methods and implications
• easy on the eyes: uncluttered data, engaging imagery
• easy on the ears: intelligible narration, music (when appropriate).

Avissar-Whiting explained that Cell Press were the first to widely adopt video abstracts and many other publishers have now followed suit. Video abstracts help authors and journals stand out from the crowd, promote communication among a broad readership or across disciplines and can represent added value for journals with high article processing charges. With the ever-increasing use of videos on social media and the internet, enhanced digital content is expected to continue to grow in popularity.

The role of RWE in a value-based world: who’s listening?

Melissa Hagan (Peloton Advantage) began the session by providing an overview of real world data (RWD) and real world evidence (RWE), their definitions, benefits and limitations, their use in health economics and outcomes research, and how they can enhance the value proposition of a drug. After reviewing the differences between randomised controlled trials (RCTs) and real world studies, she continued by outlining the potential sources of RWD, including administrative data (generally collected for reimbursement purposes), health surveys, electronic medical records, pragmatic clinical trials (prospective trials in a diverse population), and registries.

Discussing the advantages and disadvantage of RWD, Hagan noted that RWD may be used to confirm the findings or generalisability of RCTs and provide additional information which could not be obtained from RCTs, which in turn may lead to an expanded indication for a product and improved clinical care guidelines. While real world trials enable a diverse population to be assessed for a broad range of outcomes, they do have certain limitations (eg potential for bias due to the lack of randomisation and the potential for unknown/unmeasured confounding variables). However, by providing additional insights into the patient treatment journey, data on real world clinical effectiveness, and a greater understanding of economic value, RWD enhance the value proposition of a drug.

In the second half of the session, Judith Lenhart (Celgene) showed how RWD could be applied in a practical setting, using an example of patient care in elderly patients with acute myeloid leukaemia. The case study showed how RWD complemented clinical trial results by providing insights into the epidemiology, disease burden, treatment journey and resource utilisation in this setting, ultimately leading to a fuller understanding, to better inform treatment guidelines and improve clinical practice.

Following the parallel sessions, delegates could attend one of 10 roundtable discussions, which afforded delegates with the opportunity to have an in-depth conversation on their chosen topic in a smaller group setting. Day 1 concluded with the member poster presentations and reception.

Keynote address: preprints and bioRxiv

Day 2 began with the second keynote presentation of the meeting, delivered by Richard Sever (Cold Spring Harbor Laboratory Press; Editor, CSH Perspectives, bioRxiv Co-Founder) on the topic of preprints.

Preprints, unpublished manuscripts yet to undergo peer review, are not a new concept and have been established in the physics and math fields for over 25 years (eg arXiv). Preprint services are a great way of accelerating communication around data or advances in the scientific community. To illustrate this point, Sever provided an example of a preprint posted on bioRxiv (the preprint server for biology, established in 2013), which resulted in a successful research collaboration before the manuscript was published in a traditional peer-reviewed journal. Other benefits of preprint services include speed of communication, pre-publication feedback/discussion, visibility (which is especially important for junior researchers who are at an early stage in their career), and immediate availability of data to grant/hiring committees.

The uptake of the bioRxiv preprint service since its inception has been remarkable:

• ~24,000 papers posted (~1,400 posts/month)
• 30% revised
• 100,000 authors
• ~2 million views per month
• >60% papers are subsequently published
• ~1,000 journals have published biology preprints.

In addition, an increasing number of papers posted on preprint services are being tracked on the commenting platform DISQUS, with many other preprint discussion forums now available (eg preLights, PREreview, Peer Community In, Academic Karma and PubPeer).

The increased use of preprint services has led to changes in behaviour (more biologists posting, reading and citing preprints), policy (most basic research journals allow preprints), rules (funding bodies allow preprints to be cited in grants), and culture (the latest data are presented at meetings).

All scientific disciplines are covered by preprint services, with the field of neuroscience soaring ahead in the uptake of preprints and the field of biology likely to follow suit. Since the creation of bioRxiv, a number of other preprint services have launched, including ChemRxiv, PsyArXiv and SocArXiv, with MedRxiv (a proposed partnership between Cold Spring Harbor Laboratory, the Yale University Open Data Access [YODA] Project, and the British Medical Journal) set to launch later this year.

Sever ended his presentation by highlighting some of the screening issues faced by preprint services, including ethics (pseudoscience, plagiarism, patient identity) and ‘do no harm’ considerations (dual use research, vaccine safety, infectious disease transmission, drug regimens, toxicity/carcinogenicity).

Debate: do preprints have a role to accelerate the communication of industry-sponsored medical research?

Following his keynote presentation, Richard Sever was joined by Jon Druhan (AstraZeneca) and Joseph Soloman Ross (Yale University) in a thought-provoking panel debate, moderated by Brian Falcone (Oxford PharmaGenesis), on the value of preprints. Specifically, whether preprints have a role in, and will accelerate the communication of, industry-sponsored medical research.

When questioned on who stands to benefit or lose out from the use of preprints, Druhan suggested HCPs, patients (ultimately) and the pharmaceutical industry could all benefit. There is a drive to disclose data, including negative study results, as soon as possible and preprints would help with this. Moreover, preprints can help disseminate data to a wider audience.

When discussing possible misuse or irresponsible use of preprints, it was suggested that misuse was more likely to be associated with the lay media rather than with the authors themselves. The lack of peer review for preprints was also raised and it was questioned whether quality is being sacrificed for the benefit of speed. The panel noted that preprints do not remove the need for peer review but should be viewed as an avenue for rapid data dissemination, and should be clearly marked as such to avoid confusion. The panel considered how preprints will affect follow-on publications, with Sever noting there is some debate around whether preprints are citable. The panel agreed there was minimal risk of preprints spreading misinformation.

Weighing up the pros and cons, the panel believed that preprints provide pharmaceutical companies with a great opportunity to fulfil their obligation to disseminate data. However, with preprints starting to be used by the pharmaceutical industry for early research (modelling, basic science, toxicology), and the uncertainty surrounding whether regulators will view preprints as pre-approval promotion, they noted that it is important to ensure appropriate policies are put in place.

To conclude the session, the audience voted on two questions related to data dissemination via preprints: while most believed that all data (from preclinical to phase III) should be shared using preprints, most also felt that only preclinical/basic science could be shared.

Ensuring transparency: the future of authorship credit

In this talk, Monica Bradford (Science, American Association for the Advancement of Science [AAAS]) focused on the standards for authorship and contribution. Based on an increased demand for more transparency around authorship within the scientific community, Bradford described a workshop organised by the National Academy of Sciences in February 2017 and associated manuscript that provided recommendations for authorship and responsibilities. Authorship implies both credit and accountability, but the trend of having multiple authors on a paper means it is sometimes difficult to establish individual contributions. Furthermore, authorship conventions can vary between scientific disciplines, which causes confusion.

Bradford outlined the recommended criteria for authorship. These are based on ICMJE recommendations, but they have been generalised to encourage wider adoption. There are additional expectations for corresponding authors, who must:

• ensure all authors received/approved the manuscript prior to submission and received all substantive correspondence with editors as well as the full set of reviewer comments
• verify all data, materials, and code comply with the transparency and reproducibility standard of both the scientific field and the target journal
• ensure original data, materials and code are preserved and retrievable for re-analysis
• confirm that the paper accurately reflects the original data, materials and code
• foresee and minimise obstacles to the sharing of the data
• ensure the author group is compliant with best practices.

Two systems are now commonly used to help track authorship and Bradford encouraged their use. These are unique digital identifiers for authors (ORCID) and the Contributor Roles Taxonomy (CRediT) to track author contributions to the work. Many major journals have adopted ORCID as standard for first, corresponding, or all authors, and some (eg Science journals) are now implementing the use of ORCID and CRediT during manuscript submissions. When ORCID and CRediT are used together, author records can be reliably linked to publications and author contributions can be captured in the journal’s metadata, thereby enabling an individual’s author contributions to be tracked across publications and time. The Transparency in Author Contributors in Science (TACS) website is a resource showing authorship and contributor criteria, ORCID requirements, and CRediT policies of various journals.

Bradford concluded by emphasising the need to promote integrity and transparency in medical publishing and how clarifying the rules/norms will help all stakeholders to achieve this.

Following this presentation and a coffee break, delegates had the opportunity to attend two of five parallel sessions, one of which is summarised below. Two of the parallel sessions were guided poster tours that each featured three delegate posters; one tour was on the topic of ‘communicating more effectively’ and the other on ‘practical matters and professional practices’. The latter included a poster from The Publication Plan entitled ‘How do medical publication professionals engage with online news resources?’ which ISMPP members can view here.

Journal rejections: strategies for resubmission

Journal rejections are costly, both in terms of time and budget. In this session, Caroline Halford (Springer Healthcare) and moderator Gary Burd (who presented slides on behalf of Bradford Challis [Janssen]) provided their perspectives on how to minimise journal rejections. Presenting data from an analysis of journal rejections (n=34) at Janssen, Burd showed that the two most common reasons were (i) the paper did not meet the journal’s priority criteria and (ii) that the topic was not appropriate or in scope.

Recommended approaches that could limit these reasons for rejection include:

• research the journal’s scope and rejection rate
• obtain consensus on target journal early and encourage authors to be realistic
• presubmission enquiries can help gauge an editor’s interest
• draft a comprehensive cover letter along with the submission
• provide previous journal comments, indicating which have been addressed and why other comments cannot be; for issues that cannot be fixed, be transparent and consider whether they can be addressed within the discussion/limitations sections of the paper.

Focusing on the presubmission enquiry in more detail, Halford provided information on the editor’s perspective on the level of detail to include. Information such as author names, drug name, drug class, therapy area, region of development (eg US, EU, Rest of World), whether the data have been published in abstract form, how the data extend current knowledge, limitations of the research, and anticipated submission timelines were all considered to be important.

The parallel sessions concluded the morning portion of the program.

A summary of the second half of the meeting is available here.

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By Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers

A recent study published in BMJ Open brings to the fore a field that has been little-reported on to date: reporting and publication practices among health researchers in lower/middle income countries (LMICs; defined by the World Bank). The authors highlighted several potential areas of concern, relating to guest authorship, undeclared conflicts of interest, plagiarism and redundant publication.

Authors of Cochrane reviews working in LMICs were invited to complete a questionnaire that aimed to ascertain whether respondents thought that certain reporting practices were acceptable and whether these behaviours were common at their institutions. Further information was obtained through in-depth interviews. The study revealed that:

• Guest authorship is common, with 77% of participants reporting its occurrence at their institution. In-depth interviews revealed that although participants felt authorship rules are simple, they are not consistently applied.
• There is a lack of awareness about conflicts of interest and how they may affect research. Forty percent of participants indicated that their colleagues had not declared conflicts of interest in the past.
• As in high-income countries, academic status and power can affect behaviour. In some regions, junior researchers are obliged to include senior researchers on papers when they do not meet authorship criteria.
• Institutions and culture can fuel bad practice, due to an overemphasis on publications in career progression (as can also be seen in high-income countries).
• Plagiarism may be an issue; while most respondents (96%) agreed that it is unacceptable, many (37%) were aware of its occurrence among their colleagues.

In addition to undermining research integrity, poor reporting and publication practice may have a detrimental effect on the continued development of the scientific industry in LMICs. The study authors conclude that “future research in LMICs should explore ways to promote research integrity at various levels within institutions”.

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Summary by Philippa Flemming PhD, CMPP from Aspire Scientific

Gender bias is inherent in scholarly systems. Men publish at higher rates and receive more peer review invitations than women, while male PhD-educated scientists are more likely than their female counterparts to pursue tenure-track positions in academia. However, as recently reported by Inside Higher Ed, little effort has been spent trying to understand when and how gender bias in publishing originates – until now.

A new study of 1,285 recently-graduated doctoral students from an undisclosed US ‘Big Ten’ institute found that male students submitted, published and first-authored more papers than their female peers. Surprisingly, as well as being observed in male-dominated engineering and physical sciences, these gaps existed in more gender-balanced disciplines and in some potentially more female-dominated fields, such as social sciences and applied health. Preferential faculty support for males, differing career goals and the quality of student–supervisor relationships were all cited as reasons behind the gender gap. Higher levels of  research assistantships among males and of teaching roles among females were also potential contributing factors. Interestingly, this study has been backed by doctoral students from Boston University, many of whom believe the same trend exists at their institution.

These data indicate that gender differences in publishing originate early on the academic career ladder. Lead author Sarah Theule Lubienski summarised the findings as “disturbing” and contests claims that the gender gap is closing in STEM (science, technology, engineering and mathematics) subjects. The study concludes that research institutions should do more to encourage women to publish, and recommends that further research is carried out to identify the most important forms of gender bias in medical and scientific publishing.

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Summary by Emma Prest PhD from Aspire Scientific

The article states: “On 28 September, the BioMed Central journal GigaScience added the badges to two of its published papers. Readers can click to see co-authors listed under multiple badges; the information is also coded in a format that allows computer programs to extract it, which makes it linkable to other online author profiles (such as the researcher identification system ORCID). Another London-based publisher, Ubiquity Press, is also adding badges to two of its published papers.”.

The project sets 14 types of contributorship from writing and data visualisation to data curation and project management. (You can read more about this project and its other implementations here and here).

An overview of what the badges will look like is shown below.