The 14th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) took place over three days (30 April–2 May) in National Harbor, MD, and attracted a record-breaking number of visitors, with over 600 attendees.
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.
By Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers
Subscribe to Blog via Email