Preprint servers such as bioRχiv and medRχiv are becoming increasingly popular amongst researchers looking to freely and quickly share their work. The virtue of preprint severs in enabling rapid dissemination and discussion of cutting-edge science has never been more apparent than during the COVID-19 pandemic. While there are potential concerns surrounding the level of scientific rigour upheld in preprints, a recent study has shown that reporting quality in preprints is similar to that in peer reviewed articles.

A multinational author group led by Clarissa Carneiro looked at 76 preprints (from bioRχiv) and 76 peer reviewed publications (indexed on PubMed) from 2016. The authors used a checklist of objective criteria (based on existing reporting guidelines including CONSORT and STROBE) to obtain an overall score of the quality of reporting within the articles. They checked whether the articles appropriately reported basic methodological details like study eligibility criteria, statistical methods used, and whether conflict of interest and funding statements were included. The study also compared a sample of preprints with their corresponding peer reviewed versions.

The authors found that peer reviewed articles scored more highly than the preprints, but the difference was small at ~5%, suggesting comparable reporting quality.

When the authors compared preprints to their final peer reviewed versions, the single largest difference was the addition of conflict of interest information, which could be attributed to the editorial process overall as opposed to peer review specifically. Nonetheless, the authors found evidence that peer review helps select papers with better reporting for publication, scoring preprints that were later published in peer reviewed journals more highly than those not formally published.

The authors conclude that their results “seem to support the validity of preprints as scientific contributions as a way to make science communication more agile, open and accessible”.

However, the authors also suggest there is scope for peer review to have a greater impact on reporting quality.

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At the annual meeting of ISMPP this year, the way that publishers engage with preprints was identified as a key trend for the future of medical communications. In their article for the Scholarly Kitchen, Roger Schonfeld and Oya Rieger discuss this subject in more detail, drawing on a recent publication on developments in this area for Ithaka S+R.

Preprints are viewed by many as the path towards a more efficient and accelerated publishing machinery. It is now observed that not only are publishers increasingly willing to engage with preprint servers, they are also establishing integrated preprint platforms into their manuscript submission workflows.

An interesting new dimension of journal-integrated preprint sharing is the function to link the preprint with its publication status. For example, Springer Nature’s In Review service allows the progress of a manuscript to be tracked through per review, after being shared on the preprint server Research Square. If the manuscript is not accepted for publication, the preprint remains on the platform but is disassociated from Springer Nature and the submission process. While if accepted, a link from the preprint to the published article is included.

Wiley journals are offering a similar preprint service (Wiley Under Review) that enables authors to deposit and track their manuscript on the Authorea preprint server in parallel to the journal editorial review process. This service was introduced at the start of the year as a pilot and is now being expanded to 37 journals with a focus on expediting the dissemination of pandemic research.

As part of its move into preprints, Elsevier has acquired the SSRN eLibrary and developed the SSRN-compatible First Look service, which enables journals to create a branded space for preprints on SSRN. Taylor & Francis has taken the preprint process one step further with its acquisition of F1000 Research, in which a preprint is ‘published’ and then subject to open peer review and ‘post-publication’ author revision.

Challenges to this cross-platform integration include the requirement for interoperability, whereby the publisher’s submission platform(s) needs to be compatible with the preprint system. This also raises interesting ethical questions when either submission platforms or preprint servers have investment from competing publishing houses. A case in point is the Elsevier purchase of the Aries submission platform that is utilised by Springer Nature. Encouragingly, Aries now supports deposition of manuscripts via the Springer Nature Research Square functionality, showing that cross-publisher interoperability is possible.

While there is much enthusiasm for the potential of preprints to expedite research findings into the public domain and to level the financial playing field of scholarly research, some have raised concerns about potential harm in the sphere of biomedical publishing. Concerns cited include lack of identifying/tracking metadata, or indeed the implications of assigning digital object identifiers (DOIs) to preprints, the publication of unvetted claims and the need to emphasise the preliminary nature of preprints so that they are not reported by news media as established information. The introduction of a more rigorous code of practice may be a prudent next step for the preprint revolution.

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Summary by Julianna Solomons PhD, CMPP from Aspire Scientific

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

There has been much discussion of the potential advantages and disadvantages of preprints in medical publishing over recent years, and last month’s launch of medRxiv was much anticipated. While the community watches with interest to see how this new platform fares, findings from bioRxiv provide a useful indication of what we might expect to see. For instance, a recent preprint posted on the platform reports that papers posted as a preprint before being published in a peer reviewed journal have higher citation levels and Altmetric scores than other articles.

Nicholas Fraser and his co-authors evaluated articles that had been submitted as preprints to bioRxiv between November 2013 and December 2017. When compared with articles without a preprint, they found that:

• The number of citations to journal articles with preprints was 61% higher.
• The citation advantage continued 3 years after publication, with average monthly citations per paper around 50% higher for articles with a preprint.
• Articles with preprints had higher mean counts for all Altmetrics assessed (tweets, blogs, mainstream media outlets, Wikipedia and Mendeley).

The group also noted that:

• Further work is needed to identify the cause of this citation advantage, which did not appear to be driven by early access or quality effects.
• Although there was a strong preference to cite a published article rather than the corresponding preprint, citations were also made to preprints themselves, some of which were not subsequently published in peer reviewed journals. The authors highlight that the increased willingness of researchers to cite unreviewed work may be a consideration in current debates on the role of peer review.
• bioRxiv preprints themselves were widely shared on Twitter and on blogs, but received far less online attention in mainstream media outlets and Wikipedia than the final peer reviewed articles. Fraser and his colleagues suggest that, while authors are comfortable sharing preprints with their peers using informal media platforms, there may be an unwillingness to disclose non-reviewed research to the public.

The authors conclude that “In the continuing online debates surrounding the value of preprints and their role in modern scientific workflows, our results provide support for depositing preprints as a means to extend the reach and impact of work in the scientific community.”

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Summary by Debbie Sherwood BSc from Aspire Scientific

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

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, USA, and attracted a record-breaking number of visitors — over 600 attendees.

The theme of this year’s meeting, ‘From Publication to Practice: Advancing Science Through Effective Communication’, 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. The meeting also saw Chris Winchester (Oxford PharmaGenesis) begin his post as the new Chair of ISMPP Board of Trustees.

A summary of the second half of the meeting (Tuesday afternoon and Wednesday) 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 first half of the meeting can be found here.

Is pharmaceutical industry research posted as preprints?

Tuesday afternoon started with the member oral presentations, the first of which was delivered by Heather Lang (Oxford PharmaGenesis) and described her team’s research on preprints. Preprints have been the subject of much debate within the medical field in recent years and were a key topic at the meeting. Lang’s research addressed the following questions:

• Is the pharmaceutical industry posting research as preprints and, if so, what kind of research is being posted?
• Are comments on the research being posted and do authors respond to such comments?
• Have preprints been fully published and in what timeframe?

Findings showed that:

• Only around 1% of preprints on bioRxiv (an online platform for the distribution of preprints in life sciences), reported industry-authored research. Most of this was basic science; bioinformatics, genomics and genetics were the most common.
• Two-thirds of preprints were not revised on the system once posted.
• Two-thirds of the preprints from pharmaceutical companies (posted up until the end of 2016) had been published in full.

Lang acknowledged that the pharmaceutical industry could share work more rapidly using preprints than with traditional peer-reviewed publications, but stressed that education around preprints is needed. She concluded by suggesting that the industry evaluates the appropriateness of preprints for different types of research, runs pilots to explore preprint services, and develops and shares policies regarding the appropriate use of preprints.

Attention analysis simulation of scientific posters aligns authors’ intent with viewers’ focus

The second member oral presentation was given by Steve Palmisano (MedThink SciCom). This team’s research involved the use of machine learning algorithms to simulate audience visual attention via eye-tracking movements. The approach was used to evaluate the effectiveness of 16 scientific posters from a recent ISMPP annual meeting. Results showed that headlines should be kept short, especially when used on a coloured background. Graphic elements that lead the eye worked well, as did clear figures free from unnecessary elements. Use of callout boxes and displaying key results within figures were also found to be effective.

Examples of less effective posters included those that resulted in very long eye movements between areas of focus, those which drew the reader’s attention to the wrong area, and those which featured callout boxes with too much copy. Palmisano advised placing QR/VR codes strategically, when used, within the headline or conclusions box for example.

Palmisano summarised that an effective poster should draw the reader’s attention to the most important elements, enable an efficient scan path pattern that is appropriate for learning, and be visually attractive.

Publishers panel: simplifying and streamlining – working together to improve the quality of medical publications

The focus of this session, featuring representatives from major publishers, was practical advice and insights into improvements in the publishing process. Terry Materese (Elsevier) moderated the session and was joined by Chris Baumle (Elsevier), Jan Seal-Roberts (Adis, Springer Healthcare Ltd) and Caroline Halford (Adis, Springer Healthcare Ltd).

The key discussion points and take-away messages are summarised below; many of the themes that emerged aligned with focus topics for this year’s meeting.

Authorship and peer review

• Author transparency and acknowledgement of author contributions is critical; the use of systems such as CRediT should be encouraged – as discussed during Monica Bradford’s talk earlier in the day).
• A blockchain initiative is currently being trialled by Springer Nature to support the peer review process. The aim of the initiative is to create a platform where all review activity is deposited in a blockchain owned by the initiative (currently Springer Nature, Digital Science, and ORCiD), with the advantage that every deposit will be verifiable and auditable, thereby increasing transparency and reducing risk of manipulation.
• Elsevier has developed a Reviewer Recognition programme whereby peer review is a measurable research output for which credit is given. Both Springer Nature and Adis journals reward reviewers by waiving the article processing charge if they submit articles to one of their journals.

Preprints and data sharing

• A number of preprint services are now available, including bioRxiv (covered in the keynote presentation earlier in the day). Elsevier supports preprints and allows authors to share their preprints at any time on arXiv or RePEc. Other publishers, including Springer Nature, are also starting to take this approach. With the increased popularity of preprint services it will be important to update anti-plagiarism software such as iThenticate, so that preprints are not classified as plagiarism.
• Elsevier and Springer Nature have data sharing policies in place regarding the deposit of research data in relevant repositories and the subsequent citation/linking of the dataset in the article. Data in Brief (Elsevier) provides researchers with an avenue through which they can share and reuse datasets by publishing data articles.

Other themes

• Elsevier offer an Article Transfer Service whereby, if an article is deemed unsuitable for publication in a chosen journal, the editor may suggest submission to an alternative journal. The transfer can happen in minutes, negates the need for reformatting, and reduces reviewer time/burden as previous reviewer comments are pulled through. Springer Nature offers a similar process (Transfer Desk).
• The use of social media is encouraged by Elsevier and Springer Nature; both publishing houses provide guidance for authors and editors.
• Readership can be boosted by article enrichments including plain language summaries, audio slides, graphical abstracts, video abstracts and video articles.

The presentation concluded with a busy question and answer session in which the panellists informed delegates that video articles/abstracts do not have to be ‘polished’, article enrichment items adopt the same copyright as the main article, preprints remain available indefinitely, and that articles with digital features are downloaded more often than those without.

Successful integration of enhanced digital technology into scientific congresses

There are an increasing number of options available for enhancing the content of congress posters and presentations. In this session, John (Zeke) Czekanski (Fishawack US), Kimberly Della Penna (Merck) and Travis Hicks (American Society of Oncology [ASCO]) described the digital tools currently being utilised at meetings, future trends, and the pros and cons of these options in practice.

Czekanski began by providing a snapshot of current experience with digital tools and formats, based on a survey of ISMPP members and client service teams. Results revealed that most respondents had utilised various types of enhanced technology, including digital posters, virtual/augmented reality, meeting apps and QR codes. Although most considered these digital offerings to be beneficial to the end user, their value was not typically measured, suggesting that there was scope to better understand the benefits of these formats.

Della Penna summarised available technologies that offer improvements on traditional presentation types. These include the use of QR codes in oral presentations or posters, which link the user to the presentation slides, e-poster, or additional content. Unlike paper posters, e-posters can easily be made available after presentation at a congress. Videos, animation or audio commentary can be embedded within e-posters to provide greater understanding of the work, but can be expensive to develop and require advanced planning.

Hicks described ASCO’s approach to digital meeting tools. At the 2017 annual meeting, almost 3,500 e-posters and videos were accessible via the ASCO Meeting Library at digital kiosks during the congress and online afterwards. Despite the flexibility and portability offered by digitally presented content, ASCO continues to offer physical versions of posters as many attendees prefer this approach. Hicks concluded that the decision on how to consume congress material should be left to the attendee and that no single approach should be forced as it would be met with resistance.

Following this presentation, delegates had the opportunity to attend one of three parallel sessions, two of which are summarised below. The third session provided an overview of the ISMPP Certified Medical Publication Professional (CMPP) programme; more details of which can be found here.

Incorporating value into planning for early development compounds: the impact of market access trends

Emerging trends in market access and the implications for publication planners was the topic of this comprehensive presentation by Shana Traina (Janssen) and Kimberly Dittmar (Cello Health Communications). Coined the fourth ‘hurdle’ in drug development (after safety, efficacy and quality), market access is driven by many factors, as well as by payer questions regarding the value and budget impact of a drug. These include: therapeutic effectiveness, quality of evidence, perceived medical need, medical appropriateness, cost effectiveness, potential for underuse of overuse, and political expediency.

The value and budget impact of a therapy are usually assessed by governments using health technology assessments. When there are insufficient data to support value, access to a drug can be severely restricted based on clinical (eg limited to patient subgroups) and economic (eg managed entry agreement) considerations. The presentation continued with a review of the International Society for Pharmacoeconomics and Outcomes Research ’s top 10 trends in health economics and outcomes research (HEOR) and their potential impact on market access.

In the next part of the session, a case study illustrated how market access considerations (eg disease burden, clinical management, payer perspectives) can influence the scientific platform and publication plan. The example highlighted the benefits of incorporating value measures, market access factors, and HEOR data generation and dissemination plans early in the clinical development programme. The presentation concluded with a call to action — to engage HEOR stakeholders early in the drug development and publication planning processes.

Permission granted? The ins and outs of global copyrights

In this session, moderated by Sharon Suntag (IQVIA), Liz Bilodeau and Stephen Garfield (both from Copyright Clearance Center [CCC]) delved into the complex topic of copyright laws and permissions, and how the principles differ globally.

Bilodeau introduced the CCC, the basic principles of copyright, and walked delegates through Code § 106 – Exclusive rights in copyrighted works — the US guidance that covers copyright related to reproduction, distribution, derivative works and other aspects of reusing content. There are no defined international copyright laws; laws vary from country to country, and permission to use copyrighted work often excludes reuse in other countries and languages.

Exploring the complexities of global copyright in more detail, Garfield outlined how intellectual property and content sharing are guided by various policies and laws:

• treaties and agreements: eg BERNE, other treaties administered by the World Intellectual Property Organization, and TRIPS
• national laws: the two broad approaches are termed ‘continental’ in which personal rights reside with the author and are not transferred, and ‘Anglo American’ in which an economic approach to copyright and set arrangements between society and content creators is adopted
• licenses: various models exist in different countries, including statutory licenses (eg as in Germany), blanket mandates (UK, Canada), and voluntary licenses (US). Collective licensing models also exist; in these models reproductive rights organisations, such as the CCC, license the use of content from many rights holders, collect royalties, and distribute them to the rights holders
• individual company policies.

Garfield continued by discussing considerations related to open access, creative commons licenses, and the importance of obtaining permission to reuse or repurpose content. Key takeaways from the presentations are for organisations to appoint a copyright expert, create/update and communicate copyright policies, and provide effective licensing solutions for employees. Additional resources around copyright and permissions are also accessible on the CCC website.

Following the parallel sessions, delegates could attend one of 10 roundtable discussions, which afforded the opportunity to have an in-depth conversation on their chosen topic in a smaller group setting. Day 2 concluded with the annual evening networking session.

Increasing speed, efficiency and transparency in medical publishing through open access

Day 3 of the meeting began with opening remarks by Chris Winchester (Oxford PharmaGenesis and new Chair of ISMPP Board of Trustees).

The proportion of articles published open access is increasing. In this panel discussion, Valerie Philippon (Shire), David Sampson (ASCO), Maria Alu (Columbia University Medical Center) and Moderator, LaVerne Mooney (Pfizer) shared their experiences with open access from a pharma and non-pharma perspective.

Mooney began by giving an overview of open access, the current options available and the advantages it can bring; including speed of dissemination, accessibility to research and increased transparency. A poll revealed that most of the audience considered that an article being free to read was enough to qualify it as open access, whereas others considered the ability to re-use the article either non-commercially or without restrictions was important; most considered an article processing fee of less than $3000 a reasonable price for publishing open access. While governmental and charitable research funders increasingly mandate open access publishing, it is pharma that funds over half of all medical research.

To date, Shire is the only pharmaceutical company that has introduced a mandatory open access policy. Philippon discussed the impact of this policy, which was introduced in January this year, and has seen an increase from 75% to 100% of articles reporting Shire-funded research being published open access. This has resulted in an increase in expenditure on publications, but this was considered reasonable compared with other methods of disseminating clinical data (eg cost of travelling to and presenting at conferences).

Alu described her experience at Columbia University which, having implemented its open access policy in 2011, has led the way by mandating all faculty members make their research articles freely available. Alu described some of the real and perceived barriers to open access that she has encountered, such as the perception that fully open access journals are lower tier than society-led journals, which are often the first point of call for many authors.

During questions from the audience, Sampson was asked why the Journal of Clinical Oncology (J Clin Oncol; Official Journal of ASCO) did not offer open access for industry-funded research. Sampson stated that this was in part due to concerns over the re-use of content for commercial purposes. He continued to say that J Clin Oncol may in future offer open access with non-commercial use options for these articles and the journal is currently reviewing its policy. In response to a comment about the low acceptance rate for J Clin Oncol, Sampson directed the audience to potential alternatives, including the new sister journals, JCO Precision Oncology and JCO Cancer Informatics.

Member oral presentation: patient lay summaries in biomedical journals: what and how much is currently available?

Ramji Narayanan (SIRO Clinpharm Pvt. Ltd) presented findings from his study that investigated the current usage of patient lay summaries, or plain language summaries (PLS), by biomedical journals. PLS are intended to communicate vital research using simplified language, without jargon or technical terminologies, aimed towards a non-expert audience.

The study found that 44 biomedical journals currently publish PLS. These were often not mandatory and word count restrictions ranged from a single summary sentence up to 700 words; the most common was 250 words. Guidelines for writing PLS were often not given and in some cases the journal’s editorial team provided the PLS. Analysis of readability using online tests revealed that many summaries were pitched at too high a level, suggesting more patient-friendly language was still needed. Six of the journals that published PLS encouraged authors to involve patients in the writing or reviewing of the summaries, while one journal mandated patient involvement.

Narayanan concluded that there was a need to streamline PLS reporting practices among journals and maintain a consistent style and reading level. He suggested the Plain Language Expectations for Authors of Cochrane Summaries could be adapted for this purpose.

Following the oral presentation, delegates could attend one of three parallel sessions or a guided poster tour; the parallel sessions are summarised below.

“Mind the gap”— life cycle management and HEOR integration

Kristen Quinn (Peloton Advantage) and Ilia Ferrusi (Novartis Oncology) discussed how gap analysis can be used throughout the life cycle of a product and the benefits of incorporating HEOR and real world evidence.

Quinn began by differentiating gap analysis, which evaluates deficiencies in specified topics, from other similar types of research such as situation or competitor analysis. Quinn gave examples of how gap analysis can be used to answer different questions throughout a product life cycle. For example, during early stages of clinical development a gap analysis may assess the unmet needs of existing management strategies, whereas closer to product launch, there may be specific questions pertaining to patient subgroups that can be answered. Quinn recommended that analyses are routinely repeated so that new and evolving data can be used to fill existing gaps and to identify new ones. Quinn emphasised the importance of fully understanding the research question to ensure the most appropriate analysis is carried out, using quality source data, and ensuring results and their implications are communicated effectively to the client/team.

Ferrusi described how traditionally HEOR might be carried during the latter stages of a product’s life cycle to determine, for example, its relative value as an intervention. Increasingly, however, HEOR is being incorporated earlier in product development to establish unmet needs from an economic perspective, such as the cost-effectiveness of existing therapies or the economic burden of disease management. Ferrusi discussed how integrating this type of evidence into gap analysis can inform HEOR strategy and evidence-generation plans and identify opportunities for differentiation. She concluded by summarising tools that are currently available to assess the quality of HEOR and real world evidence, with a reminder to utilise non-traditional or ‘grey literature,’ in addition to traditional publications.

Lay summaries for biomedical journals

Clinical trial lay summaries will soon become a legal requirement in the EU. Although the same is not true for lay summaries published in biomedical journals, their adoption should be encouraged. In this session Jan Seal-Roberts (Adis, Springer Healthcare Ltd) and Tom Rees (Oxford PharmaGenesis) provided practical guidance on the development of lay summaries and discussed potential trends from a publisher’s perspective.

Lay summaries for peer reviewed publications facilitate readability and understanding of a research article by non-expert readers such as patients, caregivers, tax-payers, non-specialist clinicians, and by ‘time-poor’ specialists. Many patients and caregivers are familiar with scientific publications but with abstracts becoming more difficult to read, there is a growing need for publication-specific lay summaries. After the main differences between publication lay summaries and clinical trial lay summaries were presented (eg rationale, scope, endpoints included, format/style and reading age), the presentation focused on the increasing uptake of publication lay summaries.

Several journals now accept or require lay summaries, including PLOS Medicine, PNAS and Annals of the Rheumatic Diseases. Moreover, all Adis articles can be accompanied by a lay summary, which is peer reviewed. The British Journal of Dermatology now publishes a plain language summary for every accepted paper. Seal-Roberts and Rees emphasised the importance of lay summaries being made open access so that patients can find them. However, although this is the case for some journals, eg British Journal of Dermatology and those published by Adis, lay summaries are not always free accessible. It was noted that a number of non-journal opportunities for lay summaries also exist, including KUDOS, scienceOPEN, The Conversation, ATLAS of science and figshare.

Some best practice tips for developing a publication lay summary were recommended:

• focus on the significance of the research
• consider the use of infographics or visual abstracts
• use available tools to check the readability score
• consider using peers and lay readers to provide objective feedback.

Seal-Roberts and Rees concluded that publication lay summaries complement those mandated for clinical trials and have the potential to boost the impact of published research to a wider audience.

Posters of the future

In this highly engaging and interactive session facilitated by Eline Hanekamp, Niina Nuottamo, Hester van Lier and Shanthi Voorn (all from Excerpta Medica), delegates were split into groups and tasked with developing a poster. Delegates were informed that the poster must include the traditional Introduction, Methods, Results and Conclusions sections, but should be designed in a non-conventional style (eg be highly visual, interactive, employ infographics or augmented reality, have increased white space, or adopt the inverse pyramid approach to the flow of information).

After each group developed their poster all delegates reviewed all posters and discussed what made each poster effective. Examples of best practice included:

• minimal use of words
• increased focus on the results
• placing the results first or more prominently on the poster
• having a good balance of figures versus text
• having a highly visual conclusions section
• including a patient lay summary
• including QR codes linking to different versions of the poster tailored to specific audiences (eg clinicians, patients, payers).

The facilitators concluded that posters are an effective communication tool. They suggested that putting some of the discussed approaches into practice would lead to a highly engaging and impactful poster that stands out from the crowd.

News you can use

In this rapid-fire session, delegates heard updates on a number of hot topics in medical publishing, as summarised below.

Does pharma publish clinical trial data? What’s NCT number got to do with it – LaVerne Mooney (Pfizer)

Mooney reminded delegates that publications and press articles have, in the past, reported that <50% of studies do not get published, although recent analyses have shown these rates have improved. A factor that can hinder such analyses is matching a publication to its ClinicalTrials.gov record. Mooney recommended that the clinical trial registration number is included in the abstract of all submitted/published articles and, if it is not, authors should contact PubMed or the publisher to get abstracts updated/or corrected.

Right to Try bill – Juliana Clark (Amgen and Outgoing Chair of ISMPP Board of Trustees)

This US bill, which controversially allows terminally ill patients to receive investigational drugs not yet approved by the FDA, was passed by the House of Representatives on 21 March 2018. Commenting on the potential impact for medical publication professionals, Clark noted that trial recruitment may slow down, however, the bill could also result in additional relevant publications of case reports.

Patient engagement update: GRIPP2 guidelines (patients as manuscript reviewers) – Jan Seal-Roberts (Adis, Springer Healthcare Ltd)

Seal-Roberts provided an overview of GRIPP2 (Guidance for Reporting Involvement of Patients and the Public); guidance that aims to improve the quality, transparency and consistency of patient and public involvement in health and social research. Research is ongoing to assess the extent of patient and public involvement in research and medical publications. For example, a 5-year randomised controlled trial that will assess whether the lay public can enhance the peer review of journal articles.

GAPP announcement – Jackie Marchington (Caudex)

As of 2 May 2018, and after 6 years of service, the Global Alliance of Publication Professionals (GAPP), is stepping down and handing back responsibility to professional bodies, including ISMPP and the American and European Medical Writers Associations (AMWA and EMWA). The GAPP website and email address will be maintained for another ~1 year. The full press release is here.

Keynote address: the truth about doctors

In the final keynote of the meeting, a thought-provoking presentation by Hilary Gentile (McCann Health) looked at the current perceptions and roles of doctors as healthcare providers. She began by summarising some of the recent trends in the healthcare space. For example, with ~80% of the world’s health data reportedly generated in the last 2 years, doctors have been overwhelmed by information. The increased volume and access to such information also means that patients are much better informed. Additionally, time and cost pressures within health services mean doctors spend very little time with patients (2.3 minutes per patient visit for community doctors in the US) and more time on paperwork.

Gentile reported results from the ‘Truth about Doctors’ study undertaken by McCann Health. This survey of nearly 2,000 physicians from 16 countries aimed to understand the views of doctors on the “expectations and reality” of their roles. There were some surprising findings! Thirty-four per cent of survey respondents thought they could have become doctors without any training, while 53% of 18–34 year olds believed that technology could eliminate the need for doctors in the future. Doctors reported that they entered the profession to make a difference, but many felt a great sense of frustration with the current practice of medicine. This discontent is not without consequences: 66% of doctors had trouble sleeping and 58% reported marital problems.

The study showed there is a disconnect between doctors’ expectations and the reality of doctoring – but what are the solutions? Some of the insights offered by Gentile included:

• embrace and better harness the wealth of available information
• humanise new technologies to advance the doctor–patient shared care paradigm
• focus on all healthcare professional roles, not just doctors, and create new multi-stakeholder pathways to care
• empower doctors to regain mastery in patient care.

Gentile concluded that, with 80% of doctors in the survey stating they’d take the same career pathway again, the good news is the profession is unlikely to become extinct! However, the role of doctors in the provision of healthcare will almost certainly change.

Closing the meeting, Al Weigel (ISMPP President & CEO) thanked the programme, abstract and global workshop committees for their contributions, and the meeting sponsors and exhibitors. He concluded by informing delegates that an ‘ISMPP University’ webinar of the meeting highlights will be held in June, and by reminding delegates of the upcoming ISMPP West (11–12 October 2018), ISMPP EU (22–23 January 2019) and Annual (15–17 April 2019) meetings.

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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

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

Meanwhile, Public Library of Science (PLOS) announced last month that all articles submitted to PLOS journals will now automatically be published on the biology preprint server bioRxiv as preprints, ahead of ‘traditional’ publication in a PLOS journal. Following initial top-line checks by PLOS, to ensure adherence to things like ethical standards and the journal’s scope, articles will be posted to bioRxiv while undergoing peer review at PLOS in parallel.

PLOS and Cold Spring Harbor Laboratory, which operates bioRxiv, hope this collaboration will help advance data dissemination and ultimately increase the speed of research. The potential of preprints has also been explored by other groups, including the possibility for preprints to improve online article engagement and for journals to use preprint servers to identify potential articles for publication.

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Summary by Hannah Mace MPharmacol, CMPP from Aspire Scientific