The 16th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) was held on 16–18 June 2020. The 3-day meeting which, at the start of the year, was expected to be a face-to-face gathering in Washington DC, was instead held as a virtual event for the first time due to the ongoing COVID-19 pandemic. The ISMPP organisers overcame the challenges of holding sessions virtually to deliver another successful annual meeting, attracting 379 attendees!
Each of the 3 days focused on a different theme, starting with ‘Open Science’, followed by ‘Effective Communication’ and finally, ‘Evolution/Evolving Role of Med Comms’.
A summary of the third day of the meeting is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.
Robert Matheis (ISMPP President and CEO) and Todd Parker (2020-2021 ISMPP Chair) opened the final day’s presentations with an update on the changes taking place at ISMPP.
Over the past year, ISMPP has been investing in technology for better connectivity and interactivity. This year saw the addition of the ISMPP Connect online forum as a new way to stay in touch with peers and benefit from the collective expertise of ISMPP members. Existing member benefits have also been revamped with updated CMPP self-study materials and a refreshed look and feel to the COMPASS email update service.
ISMPP have also launched InformED, a new podcast, featuring interviews with distinguished experts providing entertaining and informative candour on topics in medical communications and publications. ISMPP welcomes ideas for future podcast content!
Keynote: How to write a scientific masterpiece in 2020
Corinne Williams (Journal of Clinical Investigation [JCI]) gave a journal editor’s perspective on the evolving medical publishing landscape. The JCI is an early adopter of publishing innovation having adopted a policy of making all research freely-available online in 1996.
The rise of preprints and open access policies influence the publication landscape
Medical publishing has seen a number of innovations that may change the way authors select journals. These include:
- article access and the different open access options available
- the need to comply with Plan S for those who receive funding from cOAlition S funders
- whether journals allow articles previously posted as preprints, or allow transfer directly from the health sciences preprint server, medRχiv.
Understanding the current expectations of editors and publishers for scientific manuscripts
There is an increasing expectation for authors to be transparent in matters such as author order determination, as evidenced by the introduction of author contribution statements. Williams noted that in cases of shared first and senior authorship, the pertinent contributions are often not equitable, and women are more likely to be listed second after their male counterparts.
The importance of findings being reproducible is reflected in the call for improved data integrity and transparency in reporting. This includes full disclosure of statistical tests used, replicates, randomisation of samples and blinding, and adequate description of materials. Authors are encouraged to show the full distribution of data (ie not just the mean ± standard error) to avoid over interpretation of results, and to provide uncut/unedited images of blots to prevent manipulation of results. Williams described her role at the JCI to detect and deter data misconduct, presenting some examples she had encountered of microscope image manipulation. Nevertheless, major misrepresentations of data are rare. In an audit of papers that passed first peer review at the JCI between July 1, 2017 and February 5, 2019, approximately 1 quarter were found to have issues with either statistical tests, blots or images. However, most of these were minor issues that were easily corrected or moderate issues that could be explained in the manuscript. Only a minority (3.6%) had major data integrity issues that resulted in rejection or reporting to responsible bodies.
Several sites are available for data deposition to facilitate data transparency, as appropriate to the type of research being presented:
- Genetic sequencing
- Protein structures/sequences, eg the protein data bank
- Clinical trial registration, eg gov or EudraCT
- Computer code, eg GitHub
For data for which there is no publicly available repository, supplemental data may provide a solution, although Williams noted the limited capacity of journals to host vast quantities of additional data. If supplemental data/repositories are not appropriate, Williams questioned how long it is reasonable for authors to be expected to retain data in a ready-to-share format.
How to successfully navigate changing expectations when publishing in 2020
Williams highlighted how manuscript development does not end at the point of publication. Post-publication publicity by both journals and author institutes may involve traditional channels such as press releases and website promotion combined with social media such as Twitter. New journal offerings such as graphical abstracts and video abstracts are easy to use for social media posts and provide an easily digestible summary of the manuscript on the journal website. Williams recommended restricting videos to less than 5 minutes in length as research shows people stop watching after this time, and to show the researchers behind the data in the video. When using press releases, Williams urged for a cautious take on the implications of the work, being very clear on the limitations and models being used, and making sure that a non-science audience would understand the results without over-interpreting them.
Williams concluded her presentation with a look to the future. This will be highly dependent on funders and their requirements, for example, for Plan S-compliant journal publication, or acceptance of preprints in grant applications. Changes in the metrics used for evaluating research output for hiring and promotion decisions, as well as author and reviewer acceptance of alternative forms of peer review and publishing, will also shape the future of biomedical publishing.
Synergising scientific transparency: A crash course from National Academy of Sciences discussions
Transparency is essential to successful scientific research but – despite the best efforts of many people and organisations – reproducibility and replicability continue to be generally low. Transparency requires a complete record of the research including materials, processes and results. In this session, the expert faculty reviewed ongoing efforts and initiatives to improve scientific transparency and considered their implications for publication professionals.
Richard W Davis (American Association for Cancer Research) discussed the latest report on the topic from the National Academy of Sciences, Engineering, and Medicine and work to develop a framework incorporating minimum standards for reproducibility and replicability in data analysis reporting. The need for a harmonised approach that addresses infrastructure, incentives and community was highlighted.
Leslie McIntosh (Ripeta and the Research Data Alliance), noted that a more robust approach is required to ensure transparency, emphasising that:
“Transparency is really where reproducibility begins”.
Although many articles include statements on data availability in most cases the data is not truly accessible to researchers, presenting an immediate barrier to replicability. Analysis codes are generally not shared and the analysis software is rarely specified. Alignment between stakeholders including researchers, industry, medical publication professionals and publishers, and the potential for automation to ease the practice of better science were considered as important for translating the principles of transparency into embedded practice in the scientific community. As noted by McIntosh:
“If you want better science, make better science easier”.
David Mellor (Center for Open Science) considered strategies for fostering a culture of transparency in the scientific community, reiterating the need for a coordinated and harmonized approach that addresses:
- Policy – “make it required”
- Incentives – “make it rewarding”
- Communities – “make it normative”
- User interface/experience – “make it easy”
- Infrastructure – “make it possible”
Among specific strategies discussed was the preregistration of studies with ‘in principle acceptance’ to publish regardless of outcome, so as to help avoid the misrepresentation of exploratory results as confirmatory findings in response to pressure to prioritise publishability over credibility. The dysfunctionality of the journal impact factor as a guide to the credibility of scientific research and its capacity to incentivize bad research was also discussed in the context of alternatives – such as the TOP Factor – that recognise transparency and reproducibility.
How do you do that? An interactive panel discussion on hot topics in medical communications
Common challenges and questions associated with medical communications, as determined by those most frequently mentioned in an ISMPP-member pre-meeting survey, were discussed in this engaging and interactive session. Additional questions for the panel and polling were obtained live via an audience-response system.
The panel included Alley Sullivan and Marissa Nolan (The Lockwood Group), Dee Bojanic (Gilead), and Alyssa Bowling and Samantha Koth (Sunovion).
The future model of congresses
The format that congresses will adopt after the COVID era is uncertain and different approaches have pros and cons. Live congresses offer the opportunity to interact and engage with colleagues and customers, both scientifically and socially; there are also many face-to-face activities that accompany the release of new data and these can be more difficult to achieve virtually. However, this format is associated with substantial time away from the ‘day job’, travel costs, and environmental impact.
Reflecting these disadvantages of live congresses, some meetings will certainly remain fully virtual, while others may adopt a hybrid approach. Virtual approaches offer the opportunity to expand the range of target audiences reached. But virtual congresses may become less attractive vehicles to release new research data and there are challenges with reserving one’s time to ‘attend’ such events.
‘Streamlined’ vs more traditional poster formats
In the current virtual congress environment, consumption of research data happens via interaction with a computer or mobile device, rather than a podium presentation or a face-to-face discussion with a poster presenter. To adapt to this new virtual model, it was recommended that posters should:
- be visually engaging, using infographics or impactful designs/graphics
- contain digital enhancements, such as an audio or video recording of the presenter
- have clear take-home messages prominently displayed.
Survey results communicated by one panellist showed that many people preferred these so-called ‘streamlined’ posters over traditional formats and non-poster formats, such as slide-based posters. Streamlined posters are user friendly and can be an effective way to increase engagement and interactivity.
Virtual poster ‘Q&A chat’ options
Some conferences use ‘Q&A chat’ options, which can be live or asynchronous (ie attendees submit questions for the poster author to address afterwards). This latter type of interaction is different from the virtual equivalent to a live poster session, but the approach should be the same:
- Authors should have full control over how they present the data and respond to questions.
- If an author requests pharmaceutical company support to mediate questions or answer some on their behalf, this interaction should adhere to the basic principles of ethical scientific exchange.
Considerations for presenting virtual content at conferences
Several important considerations and examples of best practice were raised:
- Authors are often frustrated with the guidelines and processes for creating, recording and uploading interactive content.
- Requirements often differ substantially from conference to conference; medical communication specialists play an important role in helping authors navigate these complexities.
- It is critical to keep authors informed of the process, including the uploading deadline and recording details/specifications.
- Be as flexible as possible with authors – recording audio, filming videos and attending Q&A sessions takes up their personal time.
Impact of COVID-19 on developing content for journals and conferences
There are many opportunities for delays in medical publishing, particularly during the current pandemic, including delays in data availability due to slower/paused trial recruitment, and extended author and journal review times.
Th following best practice recommendations were given:
- Be understanding and flexible of author circumstances.
- Use alternative methods to contact authors (eg via colleagues of the author, admin support, or regional Medical Science Liaisons of the client).
- Maintain open communication with authors, clients and journals.
- Set new expectations that there will be delays in receiving journal comments and inform journals that there may be a delay in revising drafts.
- To accommodate uncertainties around data availability and possible last-minute author unavailability, be flexible with your publication planning, collaborate with conferences, and be prepared to ‘go with the flow’.
In this interactive session, attendees were able to join the following roundtable discussions:
- Hybrid positions – an increasing trend in publications
- Tempted by the Dark Side? Learning from those who went before
- Avoiding errors in peer reviewed medical science literature
- Transparency in publication development: Scientific contributions of medical writers
- A natural selection debate: Promotional brand medical education or disease state medical education
Best practices in aligning publication content and strategic planning with Medical Information Services (MIS) and Medical Science Liaison (MSL) groups
This session, facilitated by Diane Sloan (Peloton Advantage), examined the bi-directional relationship between strategic planning teams and MSL/MIS groups, who were represented by the following panel members:
- Brian Scheckner (Jazz Pharmaceuticals)
- Mike Trabold (Jazz Pharmaceuticals)
- Elisa Park (Jazz Pharmaceuticals)
The panel described their roles and responsibilities, commenting specifically on past and present collaborations. As MSLs represent a primary peer-to-peer contact with researchers and treating physicians they are ideally placed to gather insights about how products are viewed by the medical community and to field general medical enquiries. Similarly, while responding to information requests from external healthcare professionals, MIS teams are uniquely positioned to identify both the type and volume of communications about a product, and identify key points of interest or educational gaps. By collaborating with MSL and MIS representatives, medical communications teams can leverage these unique viewpoints to plan key communication requirements, identify authors with particular research interests, and respond to frequently asked questions. In return, published materials from the medical communications teams are repurposed for MSL teams (eg slide decks) and MIS teams (eg updates to standard response letters, information at medical affairs booths) ensuring they are up-to-date with the latest company data.
Medical communications teams can leverage these unique viewpoints to plan key communication requirements, identify authors with particular research interests, and respond to frequently asked questions.
The panel discussed case studies demonstrating what this looks like in practice, for example:
- MIS teams received frequent requests for information that had no published literature to support a response. When this situation was shared with medical communications teams it resulted in the inclusion of post-hoc analyses in a publication that could subsequently be used in unsolicited data requests.
- MSL teams found different levels of understanding about treatment effect scales that were commonplace for research physicians, but not for community physicians. Sharing this information internally resulted in the publication of new analyses that were incorporated into their slide decks to enable a more comprehensive understanding of the data for all treatment providers.
Sloan rounded out this picture by voicing the agency role as a ‘keeper of institutional memory’ for a product. By acting as participants in strategic planning meetings across teams there is an opportunity for unmet needs and ideas identified by one team to be routinely recognised and shared between departments during planning meetings in order to find further opportunities to resolve educational gaps.
Mapping and navigating the new frontier of gene therapy publication planning
This session explored the considerations and challenges for publication planning in support of one of the most rapidly evolving areas of therapeutic development – gene therapies. The faculty included Eugene Tombler (CMC-Connect), Kate Lewis (Bluebird Bio) and Robin LeWinter (Orchard Therapeutics).
Gene therapies can be developed to:
- replace a disease-causing gene with a healthy copy of a gene.
- introduce a new or modified gene into the body to help treat a disease.
- inactivate a disease-causing gene that is not functioning properly.
Importantly, gene therapies offer the potential for short “one-off” treatments that can lead to lifelong benefits. More than 4,000 diseases have been linked to gene disorders, which means that successful gene therapy has the potential to positively affect millions of lives.
When planning publications for a gene therapy, consideration needs to be given to the fact that often the treatment is for a rare disease, usually the therapy is quite complex/cutting edge, and finally the treatment is often a personalised medicine. As a result, there are multiple nuances of publication planning for gene therapies:
- Frequently, the clinical trial cohorts will not be as large as those for traditional therapies and there may be fewer clinical trials to inform practice. Case studies/series and real-world evidence studies are important and there are usually multiple data cuts from clinical trials. It is important to start planning early.
- Gene therapies represent one of the most rapid transitions from academic to clinical commercial development and academic authors may not be familiar with good publication practice, necessary timelines and the legal review process. Education on these points is required and it is important to build trust with academic experts.
- Development of a lexicon is important to explain what a gene therapy is, what it does and how it was developed. Technical details are crucial, but opaque to much of the audience. A lexicon should be developed as early as possible so it can be used consistently in materials to avoid confusing external stakeholders.
- Day-to-day treaters are usually less familiar with the underlying molecular genetics of a disease because it frequently has not previously guided treatment decisions. Therefore, increased education of these treaters via publications is likely required.
- It is essential to educate patients and their families as well as clinicians when developing communications on new gene therapies.
When planning publications for a gene therapy, consideration needs to be given to the fact that often the treatment is for a rare disease, usually the therapy is quite complex/cutting edge, and finally the treatment is often a personalised medicine. As a result, there are multiple nuances of publication planning for gene therapies.
In conclusion, for the reasons stated above, publication plans for gene therapies require adjustment to those developed for traditional therapies in order to be effective.
So you have a scientific platform – what next?
The final session of the ISMPP Annual meeting was led by Karen King (CMC Affinity), Debbie Walton (Merck & Co) and Alison Humphries (CMC Connect), and explored the optimal approaches to encourage engagement with and support best use of a scientific platform, including:
- Overview of platform options
- Importance of keeping the platform up to date
- Roll out to different stakeholders
- How to track success (metrics)
Introduction to scientific platforms
A scientific platform is an internal document that provides clear, accurate, prioritised and consistent communication points across all scientific communications, and typically consists of communication themes (or ‘pillars’), key scientific statements and supporting statements.
A scientific communication platform is not….
…a brand or commercial-messaging document that includes approved statements to be used verbatim
….a compendium of all data and references associated with a product or disease state
A number of challenges may be faced during the development of a scientific platform. For example, lack of team alignment may mean that the final platform does not meet specific needs. A scientific platform that acts as a full data repository may mean that users cannot easily find what they need quickly, making it difficult to use. In addition, it is easy for a resource such as a scientific platform to become out of date. As a living document, a scientific platform should be updated regularly – at least once a year, twice a year if possible – and updates may be driven by the timing of key data releases (at congresses, for example) or a key landscape change (for example, the COVID-19 pandemic). For the scientific platform to be a robust and useful resource, it is important to ensure that such challenges are overcome. Indeed, the development of the scientific platform should be seen as the first step in the process – as already noted, it is important to ensure relevance and usability, but also to encourage adoption (and provide training if needed), and track success (for example, by collecting metrics via a survey of key stakeholders).
Format options to encourage engagement and use
A number of different options exist for scientific platforms, including:
- Word document: a low budget option that is easy to update; however, functionality is limited and it is not particularly user-friendly (which may impact use).
- PowerPoint (with navigation): a mid-range budget option that is relatively easy to update; functionality and usability are good.
- Interactive PDF: a mid/high range budget option that has good functionality and usability; however, it is not easy to update.
- Web-based (navigator): a high range budget option that has good functionality and usability (can link to other documents easily); however, it is not easy to update.
Roll out of scientific platform
A number of different approaches can be taken when rolling out a scientific platform, which may depend on where the product is in its lifecycle and who the key stakeholders are. A face-to-face workshop may be appropriate for a product that is about to launch. In contrast, a webinar or training video may be adequate for a product that is in early-stage development. In addition, some thought should be given to whether companion materials are needed for the scientific platform – for example, is a short introductory video needed to explain what the platform is and how it can be used? Perhaps users would like access to artwork/visuals and may also find a lexicon useful.
How to track success of a scientific platform
The success of a scientific platform can be measured in a number of ways. For example, a simple (and cost-effective) survey or questionnaire can be conducted, which could be repeated at intervals to identify changes. For in-depth exploration of key issues, 1:1 discussions could be held; however, they are more time consuming than a survey and discussion guides may be needed to ensure consistency. Alternatively, a focus group of users may generate debate and improve engagement; although this approach requires commitment in terms of time and budget.
Credit: Alison Humphries (CMC Connect)
The session ended with these key takeaways:
- It is important to consider usability and training, and to track the success of the platform.
- An interactive PowerPoint format seems to be the most user-friendly and cost-effective option.
- It is critical to keep the platform updated.
- Roll out is important: for a product coming up to launch, face-to-face workshops would be a useful training format.
- Guidance on how to use the platform is critical.
- Metrics can be useful for tracking the success of the platform.
Written as part of a Media Partnership between ISMPP and The Publication Plan, by Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers.