Open access in the age of a pandemic – Alemneh – 2020 – Proceedings of the Association for Information Science and Technology – Wiley Online Library

Abstract:  The COVID?19 pandemic highlighted the importance of transparency, open, and timely access to information. Open Access (OA) has the potential to increase the exposure and use of not only published research but also authoritative and reliable information. The Coronavirus (COVID?19) impacted the work of journalists, scientists, and doctors while ordinary citizens are seeking trusted information sources and the truth about the new virus. Government and private institutions worldwide are reacting to the new situation where researchers, educators, students, and staff are trying to adjust to remote teaching and learning as well as telecommuting. In March 2020, a message from the White House was sent to the Scholarly Publishing Community asking them to make all COVID?19 papers openly available and machine readable. Considering the evolving and unresolved issues around OA and scholarly communications, together with the UN 2030 Agenda (a plan of action for sustainable, universal development), this panel brings together diverse perspectives to review the current landscape of OA and shed light on the role it plays in such crises. The panel will also discuss the future implications and impact of the pandemic in the overall advancement of scholarship in general.

 

 

 

Preprints Involving Medical Research—Do the Benefits Outweigh the Challenges? | Medical Journals and Publishing | JAMA | JAMA Network

“During the COVID-19 pandemic, and perhaps thereafter, investigators may continue to want their findings released and shared as rapidly as possible, but such speed to widespread public dissemination vs sharing within a community of specialists most likely to understand the complexities of the science and concerns to public health or without rigorous editorial evaluation and peer review before publication does not come without consequences and potential for harm.29,30 For many investigators, preprints may be considered an initial step along the scientific dissemination and publication pathway, just as abstract, poster, and video research presentations at in-person and virtual scientific meetings have a role in the early sharing and discussion of studies among specialist communities before publication in a journal. While manuscripts previously posted as preprints may be improved following formal submission to a journal and undergoing editorial evaluation, peer review, revision, and editing, others may not be suitable for formal publication because of methodologic flaws, biases, and important limitations. Authors should share preprints during the processes of manuscript submission to journals, just as they do with study protocols and registration reports, to aid journal editors in the evaluation of the quality of the reporting of the study and prioritization for publication. Preprints and preprint servers are here to stay, but perhaps in the immediate future a more selective use of these sites may be warranted, with clinical investigators exercising caution when the focus of a study is on drugs, vaccines, or medical devices and the results of a study may directly affect treatment of patients.”

Why is uploading clinical trial results onto trial registries so important?

“Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

 

That is wrong. Here are the facts:

 

Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12 months of trial completion.

Best practices set out by the World Health Organization (WHO) require the results of all clinical trials to be uploaded onto a trial registry within that timeframe.

Posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows.

Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.

Results posted on registries are easier to locate and are open access.

Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.

Registry reporting facilitates comparison of trial outcomes with a trial’s originally stated aims, and thus discourages harmful research malpractices such as the ‘silent’ suppression, addition, or switching of selected outcomes, HARKing, and p-hacking.

Results on trial registries enable the more rapid and reliable identification of potential safety risks posed by medicines already on the market. …”

Why is uploading clinical trial results onto trial registries so important?

“Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

 

That is wrong. Here are the facts:

 

Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12 months of trial completion.

Best practices set out by the World Health Organization (WHO) require the results of all clinical trials to be uploaded onto a trial registry within that timeframe.

Posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows.

Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.

Results posted on registries are easier to locate and are open access.

Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.

Registry reporting facilitates comparison of trial outcomes with a trial’s originally stated aims, and thus discourages harmful research malpractices such as the ‘silent’ suppression, addition, or switching of selected outcomes, HARKing, and p-hacking.

Results on trial registries enable the more rapid and reliable identification of potential safety risks posed by medicines already on the market. …”

Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19

Abstract:  Canada has become a global leader in publicly releasing clinical data behind therapeutic products since 2019. Disclosure of clinical data is, however, limited to the point of product approval. The COVID-19 pandemic has underscored the limitations of such a point-in-time approach to transparency. As interventions are rapidly authorized for clinical trials or clinical use through emergency mechanisms despite weak evidence of safety and effectiveness, we argue that the current level of transparency must be expanded in order to mitigate potential harms to trial participants and patients, improve the reliability of clinical trials, and ultimately preserve trust in regulatory decision-making. Using existing legal powers, we explain how the Canadian regulator can and should seek to expand data transparency by making pre-clinical studies, clinical trial protocols, informed consent forms, interim analyses, and other information transparent upstream in the research process and throughout the product’s lifecycle.

The Impacts of COVID-19 on the Research Enterprise | Ithaka S+R

“The systems for communicating scholarship were stressed substantially during the height of the pandemic. The pandemic provided, in real time, a master class in the opportunities and challenges of speedy open early-stage research sharing.[90] The benefits of preprints, in enabling large-scale early-stage research communication, became apparent, as medRxiv and bioRxiv in particular saw a surge of submissions.[91] Other scientific communication has been even less formal than preprints.[92] Yet, in an environment of unrelenting public interest, and the unforeseen politicization of clinical care findings, preprint services have had to adapt rapidly, developing review systems to prevent misuse and providing disclaimers, among other changes.[93] Some observers felt these shortcomings risked launching an “infodemic of bad information.”[94] Some medical journals also launched a fast-track peer review process that demonstrated the efficiencies that could be driven, at least under emergency conditions, into their editorial processes. Many publishers made Coronavirus and related research papers freely available,[95] and some observers felt these developments were accelerating the shift towards open access.[96] At the same time, several papers evincing research misconduct were published in top-tier journals and subsequently retracted.[97] The combined effect of accelerating research communication and an endless thirst for public information about the disease led to single studies, in some cases themselves inadequate in terms of research design, driving a public narrative about potential treatments that were not thoroughly vetted.[98]…”

COVID?19 and the boundaries of open science and innovation: Lessons of traceability from genomic data sharing and biosecurity: EMBO reports: Vol 0, No 0

“While conventional policies and systems for data sharing and scholarly publishing are being challenged and new Open Science policies are being developed, traceability should be a key function for guaranteeing socially responsible and robust policies. Full access to the available data and the ability to trace it back to its origins assure data quality and processing legitimacy. Moreover, traceability would be important for other agencies and organisations – funding agencies, database managers, institutional review boards and so on – for undertaking systematic reviews, data curation or process oversights. Thus, the term “openness” means much more than just open access to published data but must include all aspects of data generation, analysis and dissemination along with other organisations and agencies than just research groups and publishers. The COVID?19 crisis has highlighted the challenges and shortfalls of the current notions of openness and it should serve as an impetus to further advance towards real Open Science.”

 

Frontiers | Preprints in Medicine: Useful or Harmful? | Medicine

“Research and its associated publications have had a considerable impact on the care and monitoring of the patients since evidence-based medicine became standard for modern medicine during the 1990s (1). Peer-reviewing is a fundamental component of scientific publication. The peer-review process first includes an evaluation of the quality and interest in the paper for the reader of the journal by the editor who, if he or she considers the article to be of interest, sends it to the external reviewers (2). If the paper is found to be interesting and of sufficient quality, the reviewers ask questions and make comments to which the researcher must respond in a rebuttal letter. If the answers are satisfactory, the article can be published. This is a time-consuming process, typically lasting months, and authors complain about the review time, which has been relatively stable since the 1980s (3)….”

Preprint manuscripts and servers in the era of coronavirus disease 2019

Abstract

Rationale, Aims, and Objectives

To both examine the impact of preprint publishing on health sciences research and survey popular preprint servers amidst the current coronavirus disease 2019 (COVID?19) pandemic.

Methods

The authors queried three biomedical databases (MEDLINE, Web of Science, and Google Scholar) and two preprint servers (MedRxiv and SSRN) to identify literature pertaining to preprints. Additionally, they evaluated 12 preprint servers featuring COVID?19 research through sample submission of six manuscripts.

Results

The realm of health sciences research has seen a dramatic increase in the presence and importance of preprint publications. By posting manuscripts on preprint servers, researchers are able to immediately communicate their findings, thereby facilitating prompt feedback and promoting collaboration. In doing so, they may also reduce publication bias and improve methodological transparency. However, by circumventing the peer?review process, academia incurs the risk of disseminating erroneous or misinterpreted data and suffering the downstream consequences. Never have these issues been better highlighted than during the ongoing COVID?19 pandemic. Researchers have flooded the literature with preprint publications as stopgaps to meet the desperate need for knowledge about the disease. These unreviewed articles initially outnumbered those published in conventional journals and helped steer the mainstream scientific community at the start of the pandemic. In surveying select preprint servers, the authors discovered varying usability, review practices, and acceptance polices.

Conclusion

While vital in the rapid dispensation of science, preprint manuscripts promulgate their conclusions without peer review and possess the capacity to misinform. Undoubtedly part of the future of science, conscientious consumers will need to appreciate not only their utility, but also their limitations.