The Good Publication Practice 2022 (GPP 2022) guidelines, which were published on 30 August, provide recommendations on how to achieve ethical and transparent publication of company-sponsored biomedical research. Learn more about the principles outlined in the new guidelines by watching this special 90-minute ISMPP U webinar, which is available to both ISMPP members and non-members.

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KEY TAKEAWAYS

• Diamond open access is a crucial facet of academic communication, but its implementation remains challenging.
• An action plan, focusing on efficiency, quality standards, capacity building, and sustainability, has been developed to further refine diamond open access.

Diamond open access (OA) is a scholarly publishing model with no fees for authors or readers. Although it is estimated that almost a tenth of academic articles are published using this practice, diamond OA is held back by certain challenges. To address these limitations, an Action Plan for Diamond Open Access has been prepared, and is currently undergoing endorsement, as described in a March article from cOAlition S.

The OA Diamond Journals Study, commissioned by cOAlition S, identified limitations associated with the technical capacity, management, visibility, and sustainability of diamond OA journals and platforms, and proposed a series of recommendations. Based on these recommendations, Science Europe, cOAlition S, OPERAS, and the French National Research Agency (ANR) have prepared an action plan focusing on:

• efficiency
• quality standards
• capacity building
• sustainability.

Each of these central elements was reviewed and discussed by participants of the February 2022 workshop on Diamond Open Access and experts of the Science Europe’s Working Group on Open Science; a summary of the action plan was presented at the Open Science European Conference 2022.

To date, over 110 organisations have endorsed the initiative.

“Endorsing the Diamond Action Plan is a sign of commitment to work together towards a scholarly publishing model that is equitable, community-driven, and academic-led and -owned. The Action Plan provides a set of priority actions to further develop and expand a sustainable, community-driven Diamond scholarly communication ecosystem.” – Marc Schiltz, President of Science Europe

Strategies to operationalise the action plan, including the Horizon Europe’s DIAMAS project (Developing Institutional Open Access Publishing Models to Advance Scholarly Communication), will be discussed at the upcoming  Diamond Open Access Conference in September 2022.

The authors hope that the action plan will increase bibliodiversity and, ultimately, “enable the global research community to take charge of a scholarly communication system by and for research communities”.

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Recorded 27 April 2022 as a MedComms Networking webinar. Produced by NetworkPharma.tv

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KEY TAKEAWAYS

• Estimated publication output of women was lower than that of men following the start of the COVID-19 pandemic.
• The gender gap was largest for productive scientists working in clinical medicine and biology.

High publication productivity is essential for furthering careers in academia. Gender disparity in publication output is a notable problem, with women traditionally publishing fewer articles than men on average. The reasons for this are multifactorial and vary by career stage, discipline, and country. Until recently, the gender gap in publication productivity was slowly diminishing; however, new evidence indicates that the COVID-19 pandemic has reversed this trend.

Recent meta-research from Dr Emil Bargmann Madsen and colleagues, published in eLife, quantified the impact of COVID-19 on the publishing rates of women and men. Using individual-level panel data on a global sample of more than 2 million publications from over 430,000 authors, the researchers found the following:

• The estimated output of women was 17% and 24% lower than that of men in 2019 (pre-pandemic) and 2020 (post-pandemic), respectively.
• The widening gender gap post-pandemic was evident for both early- and mid-career scientists, with the largest relative change in the former group.
• The increase in the gender gap was most pronounced among highly productive scientists working in clinical medicine and biology.
• Women continued to first-author publications at similar rates as in previous years, indicating a decrease in productivity rather than a shift in author roles.

The authors offer several reasons for the apparent increase in gender disparity following the start of the COVID-19 pandemic. For example, men with highest productivity may have been rewarded with access to additional workplace support, cushioning them against the impact of the pandemic. Additionally, high-achieving women scientists may have been more likely than men to allow their partner’s careers to take priority during the difficult months, which could have driven some of the differences observed.

“ The publication productivity of already prolific women scientists has been affected the most by the pandemic.”

Overall, the widening gender gap in publishing rates in the post-pandemic era is concerning, because it reflects an underlying disparity in the opportunity to succeed in science that is exacerbated by external factors. The authors call for universities, funding agencies, and policy makers to allocate resources and support to mitigate inequities resulting from the unequal disruption caused by the pandemic.

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Recorded 20 January 2021 as a MedComms Networking webinar. Produced by NetworkPharma.tv

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Earlier this year, Science published a guide to the new open access (OA) landscape that has emerged since the Plan S initiative came into effect in January 2021. The initiative requires research funded by cOAlition S members to be published OA,  which has led to a number of subscription journals changing their OA policies.

Some journals, such as Nature, introduced a Gold OA option in which authors pay a fee to have their papers published OA and immediately available to all. The top fee charged by Nature for this option is €9,500, which has been criticised by some for being too high. Such high fees can make publication financially out of reach, particularly for early-career researchers or those in lower-resource countries, further exacerbating longstanding inequalities for authors. Therefore, the American Association for the Advancement of Science (AAAS), the publisher of the Science family of journals, announced an alternative Green OA policy. This option allows authors to deposit near-final, peer-reviewed versions of papers that have been accepted in pay-for-view journals in publicly accessible online repositories (previously, manuscripts could only be shared on personal or institutional webpages). Importantly, authors funded by cOAlition S organisations will retain the rights to share their accepted manuscript openly, a condition stipulated in Plan S, and a right that will not be extended to all authors. AAAS will pilot the policy for a year to determine whether the approach is sustainable.

AAAS follow other publishers and journals, including The Royal Society and the New England Journal of Medicine, which have either had a Green OA policy for some time or have introduced them in response to Plan S. Although this approach does have its advantages, such as avoiding high publication fees, some have voiced concerns. The near-final drafts of manuscripts that are archived may lack useful sections of the final version or may not include subsequent corrections or retraction notices, making it more difficult to ensure the integrity of the scientific record. Others have argued that a focus on Green OA undermines progress to full OA. Rick Anderson, university librarian at Brigham Young University commented:

“Every open-access model solves some problems and creates other problems.”

Approximately 31% of articles in Science and 35% in Nature acknowledge grants from a Plan S funder and would therefore be able to utilise the new OA options. It is hoped that shifts in OA policies, like those driven by Plan S, will allow new findings to be disseminated faster and ultimately accelerate scientific discovery.

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Preprints are used to expedite research findings into the public domain, but their inherent uncertainty is not well understood outside the scientific community. During the COVID-19 pandemic, the need for credible and accessible heath information caused a dramatic increase in the use of preprints by media outlets. However, a recent study published in Health Communication found that almost half of 457 news articles from 15 media outlets that cited COVID-19-related preprints did not frame the preprint research as uncertain in any way.

Using two preprint servers (medRxiv and bioRxiv), Altmetrics and coding, Dr Alice Fleerackers and colleagues analysed the use of COVID-19 preprints in the media coverage of the early months of the pandemic, and assessed if and how the uncertain nature of this type of research was explained. Although almost all the news stories hyperlinked to a preprint, there was great variation in how the preprint content was covered. While 80.5% identified the content mentioned as research, nearly 20% included a hyperlink with no explanation of where it linked to or indication that it linked to a preprint.

Regardless of the use of hyperlinks, more than half of stories highlighted the scientific uncertainty associated with preprints, using a variety of framing devices, such as:

• explaining that the content was unreviewed
• identifying the content as a preprint
• adding that further verification was needed
• noting that the work was preliminary.

The authors speculate that media outlets may avoid adding explanations around preprints because simply using the word ‘research’ gives credibility to the reported content, and there may be reluctance to emphasise any uncertainty. They may also want to avoid alienating audiences who are not familiar with evaluating scientific content. However, it is encouraging that several outlets in the study reported on preprint research with adequate explanation on the uncertainty surrounding science and peer review. As the pandemic has reminded us, it is critical that the public have access to scientific research, and that it is reported by media outlets in an accurate and transparent way.

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The 9^th European Medical Writers Association (EMWA) symposium, entitled ‘Clinical Trials – New Trends’ took place on 6 May. The symposium explored the latest trends in the design, conduct and reporting of clinical trials over 3 sessions, focusing on insights relevant to medical writers and communicators.

A summary of session 2 of the symposium is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.

You can also read our summaries of session 1 and session 3.

Session 2: News in analysing, publishing and presenting clinical trial data

The second session of the symposium was moderated by Myriam Stieler (Biotronik). It reviewed recent news and innovations around clinical trial data analysis, publishing, and presentation.

Estimands in clinical trials – ICH E9 addendum

Samuel Copt (Biosensors International) opened the session with an overview of the recent addendum (R1) to the International Council on Harmonization (ICH) E9 guidance. These guidelines set out the principles of statistical methodology for clinical trials and have been around for more than 20 years. The objective of the addendum is to improve the planning, design, analysis and interpretation of clinical trials and has been implemented, or is in the process of being implemented, by regulatory authorities around the globe.

As a trial progresses, intercurrent events such as treatment discontinuation, administration of rescue medication or terminal events can affect the interpretation or outcome associated with the study objective. Copt explained that the addendum provides a framework to construct and define an ‘estimand’ or target of estimation, which specifies how intercurrent events will be handled, and “ensures alignment between trial objectives, design, protocol language, trial conduct and statistical analyses”.

The addendum [to the ICH E9 guidance] provides a framework to construct and define an ‘estimand’ or target of estimation, which specifies how intercurrent events will be handled.

Copt went on to describe the 4 attributes used to create an estimand that, when considered together, should address many intercurrent events:

• intervention – the treatment effect of interest
• population – the patients targeted by the clinical question
• variable – the variable or endpoint required to address the clinical question
• population-level summary – a measure for comparing treatments.

Copt stressed that the identification of the estimand is not solely the job of the statistician but must involve the whole clinical team, regulators, and other stakeholders. The estimand should also be clearly defined in the study protocol.

Artificial intelligence in clinical trials and healthcare

Calvin Bahr (Biotronik) gave a thought-provoking summary of where we are at the moment with artificial intelligence (AI) and its potential use in clinical trials and healthcare. Currently, AI is still in its infancy. Artificial narrow intelligence or machine learning is part of our lives – think Alexa or Siri – but it works under very controlled conditions with a limited set of parameters. In contrast, artificial general intelligence relies on machine intelligence, and is still a theoretical process. Artificial super intelligence would require machine consciousness and, for the moment, is the domain of science fiction.

Machine learning could be used throughout the clinical trial process.

Bahr explained that machine learning could be used throughout the clinical trial process:

• trial design – risk assessment using data from prior trials and publications
• trial setup – improve patient enrolment by mining databases to match patients with trials
• trial conduct – monitor disease progression through analysis of biomarkers
• trial closure – data cleaning.

Machine learning is already being used in general healthcare. For example, retinal images can be analysed automatically for diabetic retinopathy, giving results in under 30 seconds. These programs can be superior to physicians at spotting early disease. AI has also been used to predict clinical outcomes based on electronic health records, but there is still more to do to improve reliability.

Different requirements for presentations held on virtual events

Next up, John Gonzalez (Solanum Medical Communications) discussed how the development of presentations for virtual meetings, which were thrust upon us last year, has been a steep learning curve for us all. Gonzalez described some of the challenges and benefits of virtual poster sessions:

Gonzalez outlined the different requirements and the potential opportunities that are available for enhancing virtual presentations. A crucial factor to address is gaining the attention of your audience: Gonzalez explained that the average human attention span has decreased from 12 seconds to just 8 seconds over the last 20 years. People are bombarded with information, most of which they do not take in. This was perhaps being realised even before the pandemic, with the congress poster evolving from the traditional wordy, overly complex “manuscript dump” to a more visual and graphical, and less textual, version.

Interactivity, allowing interrogation of the information with enhanced content, can be one way to keep your audience engaged. Gonzalez recommended that posters should be visually attractive with added value available (such as voiceovers, additional data, animations, or videos) to get the most out of a virtual presentation. With the hybrid congress model likely to become the norm, interactivity or enhanced content should be at the front of our minds when beginning the poster development process. Author buy in is needed from the start.

Interactivity or enhanced content should be at the front of our minds when beginning the poster development process.

Gonzalez finished his presentation with a warning to be aware of predatory conference websites. These sites may look legitimate and may even have been cloned from the original, authentic website. He recommended taking a minute to ensure you are submitting on the correct site.

New trends in publishing

The final presentation of the session was given by Caroline Halford (Digital Publishing Manager, Adis journals). She provided an overview of many of the current trends in publishing, including:

• Open access initiatives

Halford explained the concept of transformative journals as a way for publishers to become compliant with Plan S. A hybrid journal can apply for transformative journal status, requiring a commitment to become fully open access as soon as possible. Halford signposted attendees to the Journal Checker Tool to help identify Plan S compliant publication routes for their research.

• Registered Reports

The popularity of Registered Reports has grown significantly over recent years with over 200 journals now accepting this format. Halford highlighted benefits including the increased transparency of trials and the potential to improve rates of publication of null findings.

• Data sharing and digital features

Data sharing and access to additional digital features were discussed as ways to increase the impact of an article. However, attendees were reminded to consider the inclusivity of enhanced content and to incorporate, for example, subtitles or transcripts with audio or video files to ensure accessibility to all.

Attendees were reminded to consider the inclusivity of enhanced content and to incorporate, for example, subtitles or transcripts with audio or video files to ensure accessibility to all.

• Innovations in peer review

Halford outlined recently introduced strategies where authors submit to a publisher rather than a specific journal, receiving a proposed target journal with their review comments. If the authors decline the offer, they are free to take their comments elsewhere. It is hoped that this will reduce the need for multiple rounds of peer review and accelerate the publication of research.

• Preprints

Halford touched on the challenges arising from media uptake of preprints over the past year. Sensationalised headlines may grab the public’s attention, but the media must do more to explain that data and information from preprints should be viewed with caution as these are yet to be peer reviewed.

The media must do more to explain that data and information from preprints should be viewed with caution as these are yet to be peer reviewed.

• Plain language summaries

Finally, Halford stressed the importance of plain language summaries as more and more patients are searching for information. She reminded attendees to look out for the inclusion of a patient section in the fourth iteration of the Good Publication Practice guidance (GPP4).

Why not also read our summaries of sessions 1 and 3 of the symposium?

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Written as part of a Media Partnership between EMWA and The Publication Plan.

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