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To Preprint Or Not To Preprint: Debate At ISMPP Annual Meeting

To preprint or not to preprint: A debate at the ISMPP
Sandeep Kamat
Written by Sandeep Kamat

The Covid-19 pandemic has brought with it a deluge of preprints. While timely sharing of knowledge has helped us in forming an efficient response to the control the ongoing crisis, how do we strike a balance between open sharing of information and reducing the confusion generated by information overload? I attended a debate session at the Virtual 17th Annual ISMPP Meeting to delve into this topic. Moderated by Lisa Jolly, Senior Scientific Specialist, Parexel, the session was titled A preprint pandemic: the evolving role of preprint servers in the COVID-19 era & Preprint debate – to preprint or not?, and had an impressive line-up of speakers, namely, Richard Sever, Assistant Director, Cold Spring Harbor Laboratory Press; Joanne Walker, Future Medicine; Tim Koder, Communications Director, Oxford PharmaGenesis; Meghan Johnson-Watson, Global Publications Leader, Oncology, AstraZeneca; and Janet Davies, Global Publications Lead, UCB Pharma.

Below is a summary of all that was discussed.

Preprints are unpublished manuscripts yet to be certified by peer review. bioRxiv was launched in 2013 as a preprint repository for the biological sciences and currently hosts 120,000 papers. medRxiv was launched in mid-2019 to meet the enhanced screening and more rigorous ethical requirements for dissemination of clinical information and hosts >16,000 medical preprints. Both repositories are non-profit and offer free submission and access.

In this session, speakers representing the publisher, the pharmaceutical industry, and the preprint server shared their perspectives on the evolving role of preprints. This was followed by a debate in support of and against the use of preprints for dissemination of clinical trial results.

Publisher perspective

A significant increase in preprints, including both Covid-19 and non-Covid-19 publications, has been observed over the past few years. Advantages of preprints include swift access to new research findings, an open review model, and insights into ongoing research.

During the pandemic, STM publishers encouraged authors to post their manuscripts on preprint servers, which is not considered prior publication. However, authors may be reluctant to do so since journals lack a consistent policy on preprints.

Preprints facilitate an open, collaborative peer review process; however, <10% of preprints receive comments. Authors may consider rapid peer review options offered by journals to avoid publication delays.

Industry perspective

Publication timelines were stretched during the pandemic because of delays in receiving author comments or feedback from journal reviewers. This led to limited opportunities for rapid review of publications. Congress deadlines were extended, and little time was available between abstract acceptance notification and the congress presentation.

Preprints may be an attractive option for data dissemination given the challenges associated with timely publication during the pandemic; however, only certain types of data, for example, academic research data or preclinical data not related to investigational products, seem suitable for preprints. Clinical data  are unsuitable for posting as preprints because absence of peer review may lead to compromised data integrity and inaccuracies in reporting. There are also concerns about data misinterpretation as well as off-label misuse.   

Considerations around use of preprints

Preprint use considerations

Preprint server perspective

Rapid communication is critical during pandemics. In 2003, 93% SARS-related papers were published after the epidemic was controlled. In contrast, ~14,000 preprints were available in 2020 during the ongoing pandemic. Some preprints accelerated dissemination of critical information as evidenced by their high usage statistics.

Example of a highly accessed preprint

A highly accessed preprint
A

Covid-19-related preprints provided access to early epidemiological observations, immunological response, virus structure and biology, data from observational studies of Standard-of-care treatment, and clinical trial results of hydroxychloroquine, tocilizumab, convalescent plasma, and dexamethasone.

During the pandemic, bioRxiv and medRxiv preprints are being screened by PhDs or MDs for general criteria such as plagiarism, concerns around compromising patient identity, and adhering to ethical standards as well as the overall principle of “do no harm,” for example, dual-use concerns, papers challenging vaccine safety and public health measures, or those propagating conspiracy theories or concerns around drug availability.

In future, traditional journal peer reviews may be augmented by portable peer review platforms, commenting platforms, and services offering automated analyses of content.

Alternative venues for rapid peer review of Covid-19-related literature posted on preprint archives

Rapid Reviews

Summary of the debate representing views in favour of and against the use of preprints of clinical trial papers

Favoring the use of preprintsAgainst the use of preprints
– All preprints cannot be considered to have less scientific rigor
– Journals recommend preprints to avoid delays
– Preprints increase scientific collaboration and have resulted in exchange of data and experimental materials, thereby furthering scientific research
– Misinterpretation not restricted to preprints; press releases provide no data, whereas preprints provide access to data
– Preprints are not considered the final publication and have no bearing on regulatory approval
– Preprint process can be improved to derive maximum benefits for all stakeholders
– Preprints need not be restricted to Covid-19-related papers and should be extended to other important disease conditions as preprints promote research activities

– Extraordinary circumstances necessitated the use of preprints, and this may not be an ongoing need
– Risks associated with preprints of clinical publications far outweigh the benefits
– Chances of misleading information being posted due to limited checks and balances
– Scope for misinterpretation of results by media and patients
– Difficult to retract once incorrect information has been disseminated; preprint revisions are not effective>50% preprints are never published
– Increased liability from being perceived as promotional or due to off-label use
– Little control over comments and author responses
– Lack of consistency in reporting standards for clinical trial transparency: 33% preprints do not have clinical trial registration number or disclosures

Result of audience poll after presentation

Audience poll on preprint use
Audience poll on pre

This article is a part of report on 17th Virtual Annual Meeting of ISMPP. Click here to get your copy of the comprehensive report today.

About the author

Sandeep Kamat

Sandeep Kamat

Sandeep Kamat is Vice President, Quality & Training, at Cactus Life Sciences.

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