KEY TAKEAWAYS

• The FAIR (‘findable’, ‘accessible’, ‘interoperable’, and ‘reusable’) principles of data management have now been applied to the development of research software.
• The FAIR for Research Software (FAIR4RS) principles have been published alongside practical illustrative examples, to give researchers clear guidance on their implementation.

Despite the publication of the FAIR (‘findable’, ‘accessible’, ‘interoperable’ and ‘reusable’) principles of data management in 2016, data discoverability continues to be a challenging field, hampered by issues such as lack of awareness and inadequate implementation. An article by Michelle Barker et al in Scientific Data outlines how FAIR principles can be applied to the development of research software, to improve data management and stewardship.

FAIR principles can be applied to the development of research software, to improve data management and stewardship.

Developed by the FAIR for Research Software (FAIR4RS) working group, the FAIR4RS principles recommend that software and, when relevant, associated metadata are:

• Findable: simple for humans and machines to find, including via a unique identifier, and described by rich metadata
• Accessible: retrievable using standardised protocols
• Interoperable: interoperable with other software and/or by application
• Reusable: “Can be understood, modified, built upon, or incorporated into other software”.

The authors provide three real-life examples of the successful implementation of the FAIR4RS principles, to give researchers clear, practical guidance:

1. A command-line tool: Comet is an open-source tool. The details of its development, its metadata, and the software itself are all freely available and findable.
2. Complex research software: The software PuReGoMe analysed real-time data on public attitudes during the COVID-19 pandemic. The software has a unique identifier and independently accessible metadata that are searchable and indexable.
3. Graphical user interfaces: gammaShiny is available in a national archive under a public licence and has a persistent unique identifier.

The aspirational FAIR4RS principles provide a means to further improve the transparency and reproducibility of research. To ensure their effective implementation, software owners and developers should consider the principles early in the development process.

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KEY TAKEAWAYS

• The systems for finding, training, and incentivising peer reviewers may need to change to meet current demand.

Peer review has developed as a means of establishing quality control in research, but can current processes keep up with rapidly increasing research volumes? In a recent Nature Career Feature article, Amber Dance reported on the difficulties and ideas for overhauling the system, drawing on the experiences of a range of stakeholders in the peer review process.

Several issues with current peer review processes were raised:

• It takes time. Aczel et al estimated that in 2020, reviewers worldwide spent over 130 million hours (nearly 15,000 years) reviewing articles.
• It is often unpaid work. While this might reduce the risk of bias, it makes peer reviewing unfeasible for some.
• Reviewers are becoming more selective about the work they are willing to take on. Some now only peer review for not-for-profit journals or preprints, where they focus on the science rather than suitability for a given journal.
• There is underrepresentation of junior researchers and those from countries with less well-established research infrastructure.
• It can be a slow process, sometimes resulting in delays to publication and the ability for research to shape policy, for example. In some cases, processes may even drive researchers to leave academia altogether.

Reviewers are becoming more selective about the work they are willing to take on. Some now only peer review for not-for-profit journals or preprints.

Dance explored opinions on how peer review could change, such as:

• Incentives for researchers’ time. This might vary from a free journal subscription to the more controversial issue of journals paying for reviews. Other incentives might include giving more recognition to named peer reviewers.
• Peer review training for early-career researchers and those in lower-income countries, to increase the pool and diversity of potential reviewers.
• Increasing the use of technology to check aspects of statistics or methods, for example.
• Reducing the number of reviews needed through increased screening of submissions prior to peer review, allowing authors to ‘recycle’ reviews for a related journal submission, or enabling submission of reviews collected before an initial submission (such as those from eLife reviewed preprints).

Drawing on these perspectives, many changes could be made to peer review – we look forward to seeing how processes may evolve in future.

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KEY TAKEAWAYS

• Reporting guidelines recommend that researchers factor the role of sex into animal and clinical studies, but progress in adherence to these guidelines has been slow.
• Sex-based analyses have led to some key medical discoveries, and researchers are encouraged to examine data for sex differences to enhance study reproducibility and open up questions for scientific pursuit.

Medical research funders and publishers are increasingly calling for the role of sex to be considered in preclinical and clinical studies. In a recent Nature News Feature article, Dr Emily Willingham highlights the importance of reporting sex differences in medical research and examines why progress in this area has been slow.

Sex as a variable has important health implications. A recent example is COVID-19, which has higher mortality in men but affects more women in the form of long COVID. Accounting for sex can enhance the scientific rigour and reproducibility of a study, and even if there are no sex-based differences to report, negative findings are still informative.

Accounting for sex can enhance the scientific rigour and reproducibility of a study, and even if there are no sex-based differences to report, negative findings are still informative.

Yet, since the thalidomide tragedy in the late 1950s, women of childbearing age have been under-represented in clinical trials. Progress was made in the early 1990s, when the US National Institutes of Health (NIH) began requiring that women are included in clinical research. Both the NIH and EU now call for both sexes to be included in cell and animal studies.

In 2016, Dr Shirin Heidari led the publication of the Sex and Gender Equity in Research (SAGER) reporting guidelines, with the aim of encouraging authors to consider sex and gender differences in scientific publications. However, progress in adherence to these guidelines has been slow. An analysis of 720 papers published in 34 biology journals in 2009 and 2019 found that although the proportion of sex-inclusive studies had risen, the proportion incorporating sex-based analyses had decreased from 50% to 42%. Another study reported that even when sex is considered as a variable, treatment effects are often not compared properly between sexes, leading to misinterpretation of data.

The reasons for the relatively slow uptake of sex inclusion and reporting policies include:

• general resistance to change – some journals assert that the SAGER guidelines are not applicable to their fields
• cost – mice studies that include two sexes require more animals, which adds expense
• complexity of sex – some researchers argue that a binary definition based on specific anatomy or chromosome numbers is too limiting.

Encouragingly though, since sex inclusion guidelines were put in place, important medical discoveries have been made. One key finding is that risk of cardiovascular disease begins to rise at a lower blood pressure in women than in men – a revelation that came about from a call for studies looking specifically at sex differences in health outcomes. Considering the potential implications for medicine, we hope to see more researchers incorporate sex-specific analyses in their studies.

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Recorded 02 November 2022 as a MedComms Networking webinar. Produced by NetworkPharma.tv

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KEY TAKEAWAYS

• Social media can facilitate transparency and extend the reach of scientific communications.
• Key steps in using social media to disseminate scientific data include defining the strategy, ensuring alignment of content with applicable policies and guidelines, tailoring posts to target audiences, and monitoring engagement.

A recent ISMPP podcast discussed the opportunities and challenges for social media in medical communications.

Caroline Shepherd and colleagues explored this topic further in ISMPP’s newsletter, where they provided tips on how to extend the reach of scientific data via social media channels.

1.  Determine the purpose and ensure alignment and approval within the organisation.

• Map the social media landscape for scientific communications to inform execution and identify a way to distinguish your organisation from others.
• Create an identity, purpose, and voice for the social media presence by developing organisation-wide best practices for handle naming, ownership, management, and monitoring of audience engagement.

2. Establish a cross-functional social media leadership team responsible for the development of compliant processes, oversight of strategy and its execution.

• Ensure the posts and interactions are compliant with industry regulations and social media policies.

“…for the pharmaceutical industry, scientific communication with healthcare professionals and the general public occurs through scientific exchange that must be compliant with industry regulations. This includes the use of social media approaches both in the active provision of non-promotional information, and for responding to unsolicited requests received through social media.”

3. Provide content aligned with your organisation’s values and in a format preferred by the target audiences.

• Select optimal platform and tailor the style, type, format, and timeliness of the information posted to audience needs and preferences.
• Develop a style guide, lexicon, templates, and creative assets to maintain consistency.
• Incorporate polls, questions, videos, and visuals to make content more engaging.
• Align posts to your publication plan and ensure quick and tailored responses to comments; consider 24-hour monitoring for adverse events.
• Agree on best practices for integrating the social media activity of each publication stakeholder into the publication development processes.

4. Monitor audience engagement and adapt the process and content accordingly. Depending on the overall goals for the social media activity, the following metrics can be used to measure engagement:

• clicks to publications
• post views/impressions
• dialogue/appreciation/amplification rates (number of replies/likes/shares per post)
• handle followers.

To conclude, the authors highlighted the importance of having realistic expectations about what can be achieved using this approach, and of learning from each social media initiative launched.

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KEY TAKEAWAYS

• The journal eLife has abolished accept/reject decisions and established a new model for research dissemination.
• All papers assessed by the journal will now be published as reviewed preprints, featuring open peer reviews and a further, standardised assessment.

Following eLife’s 2021 policy to make preprinting a mandatory requirement ahead of submission, the journal has recently stopped accepting or rejecting papers after peer review. Instead, eLife will publish ‘reviewed preprints’, which they hope will bring together the diligence of peer review and the fast pace of preprint posting.

The reviewed preprint format will see all papers that are accepted for review posted online. They will appear alongside open peer reviews and an eLife assessment, which summarises editor and peer reviewer opinions on the paper’s impact and strength of evidence. These assessments are tailored to non-experts and use standardised language, akin to a grading scale. Authors also have the opportunity to include a response to the reviewer comments and assessment. After posting, authors can choose to take no further action, submit a revised version of the paper, or deem the article the final version of record to be indexed on PubMed.

eLife have shared various benefits that they believe this approach will offer:

• increased transparency around author–reviewer communication
• improved communication of intricate reviewer thought processes
• greater accessibility for non-expert readers
• greater autonomy for authors
• increased emphasis on paper content, as opposed to publisher title
• faster mobilisation of scientific content.

Editor-in-Chief Michael Eisen has described the major shift in approach as “relinquishing the traditional journal role of gatekeeper” in favour of a system tailored to scientists rather than publishers.

eLife editors expressed their hopes that this transparent review model will encourage readers to judge a paper by its content as opposed to the journal it is published in.

In a recent editorial, eLife editors expressed their hopes that this transparent review model will encourage readers to judge a paper by its content as opposed to the journal it is published in, and that it will “become the norm across science”.

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KEY TAKEAWAYS

• Gender inequity persists in medical research and medical publishing.
• As we mark International Women’s Day 2023, we sum up recent posts from The Publication Plan on studies, guidelines, and initiatives from groups striving for change.

In 2023, International Women’s Day calls on us all to #EmbraceEquity. This theme challenges us to think about the key differences between equity and equality and to consider why “equal opportunities are no longer enough”. In other words, why we should aim for equal outcomes, rather than equal resources. At The Publication Plan, we’ve reported on a number of studies, guidelines, and initiatives that aim to shine a light on gender bias and pave the way to gender equity in medical publishing.

As we’ve reported, gender gaps currently persist at each level of medical publishing and in fact worsened as a result of the COVID-19 pandemic:

• Research participation and reporting: Historically, medical research focused on white males, leaving other groups underrepresented. In an interview with The Publication Plan, Shirin Heidari (lead author of the Sex and Gender Equity in Research [SAGER] guidelines) outlined why she believes that sex and gender differences are still not given enough consideration.
• Authorship and citations: An analysis of over 5,500 papers found that those authored by women were less likely to be cited, particularly if both the first and final authors were women.
• Peer review and editorial boards: An analysis of the British Medical Journal publishing group found that fewer than 1 in 3 peer reviewers were women, potentially influenced by greater ‘invisible workloads’ shouldered by women in academia and lower visibility among the pool of senior researchers considered for peer review roles. The same study reported that women accounted for only 1 in 5 Editors in Chief.

So, how do we move towards a more equitable landscape? A number of groups have proposed ideas and recommendations:

• The SAGER guidelines provide a means to report both sex and gender-related dimensions in research.
• A group of female and nonbinary scholars have made recommendations for improving equity and social justice in medical publishing.
• Altmetrics may provide a tool to help overcome the gender bias that continues to affect career progression in academic research.
• Good Publication Practice 2022 highlights the importance of inclusivity in research, authorship, and publication planning.
• Publishers have launched a global initiative to track equity, diversity, and inclusion parameters in publications, with the ultimate aim of improving diversity and representation.

International Women’s Day calls for us all to take action to drive gender parity – we look forward to seeing how collaborative approaches in medical publishing help us to reach this goal.

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KEY TAKEAWAYS

• PMCPA has provided detailed guidance on how pharmaceutical companies should use social media.
• Pharmaceutical companies are free to use social media but must ensure their communications and interactions are compliant with regulations.

UK pharmaceutical companies cannot advertise prescription-only medicines to the public or promote a drug before it has regulatory approval. This activity is largely self-regulated, with companies signing up and abiding by The Association of the British Pharmaceutical Industry (ABPI) Code of Practice (ABPI Code). The system is long-established but has not to date addressed the use of social media by pharmaceutical companies in detail. New guidance has now been released by The Prescription Medicines Code of Practice Authority (PMCPA), who administer the ABPI Code. The PMCPA guide provides practical advice to pharmaceutical companies on how they can use social media in compliance with the ABPI Code.

The guidance includes some overarching considerations and also detailed guidance on the following social media activities:

• linking to information within social media posts
• mentioning of other accounts
• hashtags and tagging
• responding to misinformation
• signposting vs posting/sharing/re-sharing
• posting corporate news and announcements
• constructing compliant social media profiles and job advertisements
• increasing disease awareness for the public
• providing patient support
• advertising meetings and events
• announcing product and pipeline milestones
• working with social media influencers
• promoting to health professionals and other relevant decision makers
• recruiting clinical trial participants.

The guidance makes it clear that all material disseminated and activities carried out by a pharmaceutical company, its employees (even through personal accounts if they relate to professional matters), or any third parties acting on its behalf on any social media channel may come within the scope of the ABPI Code and is the responsibility of the pharmaceutical company. This guidance represents the first of its kind in the UK and it is hoped that it will address some of the compliance challenges that have been faced by UK pharmaceutical companies in the absence of clear and codified guidance. To learn more, why not watch the recent MedComms Networking Webinar on the subject or review the PMCPA’s resources for pharmaceutical companies?

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KEY TAKEAWAYS

• US guidance mandates that, from 2025, all publicly funded research is open access from the time of publication.
• The publishers of Science highlight the importance of equitable access for both readers and authors, and propose immediate green open access as one of the potential solutions.

In recent years, Europe has seen Plan S accelerate open access to publicly funded research. Now, guidance from The White House Office of Science and Technology Policy mandates that, by 2025, all publicly funded research in the US must be open access at the time of publication. As publishers consider how best to meet this requirement, the American Association for the Advancement of Science (AAAS), publishers of Science, have proposed one solution and called on others to join the discussion.

In a recent editorial, AAAS set out some of the key challenges faced by publishers as they seek to “balance the tensions between equitable access for readers and equitable access to publishing”. In other words, how can publishers ensure readers have open access to articles while ensuring researchers can equitably obtain open access publication? The authors highlighted that while the current commonly employed open access model, based on payment of article processing charges, ensures open access for readers, it can result in a system skewed to well-funded senior researchers (who are often white males).

While one of Science’s journals operates under this gold open access model, the publisher plans to use immediate green open access as a tool to meet the US mandate for its remaining, currently subscription-only journals, as outlined in a recent Nature news article. Authors of publicly funded research accepted by these journals are now able to utilise the ‘green open access-zero day’ policy, posting their peer reviewed, author accepted manuscript in a public repository without additional journal fees. AAAS has invited further discussion within the research and publishing communities to refine approaches to open access, stating: “We must not sew more structural inequity into the very fabric of the enterprise we seek to improve.”

AAAS has invited further discussion…to refine approaches to open access, stating: “We must not sew more structural inequity into the very fabric of the enterprise we seek to improve.”

To this end, Science correspondents have begun to share their thoughts and proposals, including suggestions for international standards for article processing charges and open access publication and to designate articles as open access only after a publication decision is reached. Both strategies are aimed at ensuring publication quality is protected over volume.

The ongoing discussions illustrate that providing an open access publishing system that is equitable, fair, and inclusive remains challenging. As outlined by AAAS, such a challenge requires publishers to work together with governments, funding bodies, and the wider scientific community to find a mutually agreeable way forward.

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KEY TAKEAWAYS

• Turnaround time is a key consideration during journal selection.
• The average time from manuscript submission to publication has reduced by 36 days in the last 10 years, mainly thanks to gains at the production stage.

A journal’s turnaround time (TAT), consisting of the peer review and production stages, is key to authors during journal selection, only outranked in importance by journal’s reputation, Impact Factor, and readership. A recent article written by Christos Petrou for The Scholarly Kitchen reports that the average TAT has become shorter in the last decade, putting rigour of the peer review process in question.

TAT decreased from 199 days in 2011/12 to 163 days in 2019/20, with the reduction seen primarily at the production stage (23 days) but also at peer review (14 days).

Petrou assessed over 700,000 randomly selected papers published in more than 10,000 journals owned by 10 of the largest publishers. He found that the TAT decreased from 199 days in 2011/12 to 163 days in 2019/20, with the reduction seen primarily at the production stage (23 days) but also at peer review (14 days). Petrou suggests that the gains at the production stage were caused by:

• shift to continuous online publishing model, whereby articles are posted as soon as they have completed production, ahead of their inclusion in a final print or online journal issue
• rise in early publication of pre-Version of Record  articles (journal pre-proofs), which have yet to undergo copyediting, typesetting, and author corrections.

Of note, the acceleration of peer review was driven predominantly by 2 publishers, with the others showing a static or even deteriorating performance. Additional data from one of the two publishers with large gains in peer review speed demonstrated that high editorial standards could be maintained despite decreased TAT. This led Petrou to question whether the slow(ing) performance of other publishers could be the result of operational inefficiencies.

The article highlights the need for, and importance of, a central platform providing TAT metrics to help authors identify suitable journals for their publishing needs.

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