Pandemic scientific data sharing recommendations: examining and re-imagining pre-print servers after the end of the world-wide emergency | Antimicrobial Stewardship & Healthcare Epidemiology | Cambridge Core

Abstract:  Early in the pandemic, pre-print servers sped rapid evidence sharing. A collaborative of major medical journals supported their use to ensure equitable access to scientific advancements. In the intervening three years, we have made major advancements in the prevention and treatment of COVID-19 and learned about the benefits and limitations of pre-prints as a mechanism for sharing and disseminating scientific knowledge.

Pre-prints increase attention, citations, and ultimately impact policy, often before findings are verified. Evidence suggests that pre-prints have more spin relative to peer-reviewed publications. Clinical trial findings posted on pre-print servers do not change substantially following peer-review, but other study types (e.g., modeling and observational studies) often undergo substantial revision or are never published.

Nuanced policies about sharing results are needed to balance rapid implementation of true and important advancements with accuracy. Policies recommending immediate posting of COVID-19-related research should be re-evaluated, and standards for evaluation and sharing of unverified studies should be developed. These may include specifications about what information is included in pre-prints and requirements for certain data quality standards (e.g., automated review of images and tables); requirements for code release and sharing; and limiting early postings to methods, results, and limitations sections.

Academic publishing needs to innovate and improve, but assessments of evidence quality remains a critical part of the scientific discovery and dissemination process.

Data sharing implementation in top 10 ophthalmology journals in 2021 | BMJ Open Ophthalmology

Abstract:  Background/Aims Deidentified individual participant data (IPD) sharing has been implemented in the International Committee of Medical Journal Editors journals since 2017. However, there were some published clinical trials that did not follow the new implemented policy. This study examines the number of clinical trials that endorsed IPD sharing policy among top ophthalmology journals.

Method All published original articles in 2021 in 10 highest-ranking ophthalmology journals according to the 2020 journal impact factor were included. Clinical trials were determined by the WHO definition of clinical trials. Each article was then thoroughly searched for the IPD sharing statement either in the manuscript or in the clinical trial registry. We collected the number of published clinical trials that implemented IPD sharing policy as our primary outcome.

Results 1852 published articles in top 10 ophthalmology journals were identified, and 9.45% were clinical trials. Of these clinical trials, 44% had clinical trial registrations and 49.14% declared IPD sharing statements. Only 42 (48.83%) clinical trials were willing to share IPD, and 5 (10.21%) of these share IPD via an online repository platform. In terms of sharing period, 37 clinical trials were willing to share right after the publication and only 2 showed the ending of sharing period.

Conclusion This report shows that the number of clinical trials in top ophthalmology journals that endorsed the IPD sharing policy and the number of registrations is lower than half even though the policy has been implemented for several years. Future updates are necessary as policy evolves.

UAEM Netherlands Pushes For Clinical Trial Transparency — Universities Allied for Essential Medicines

“On June 20th, Universities Allied for Essential Medicines Netherlands (UAEM NL) called upon the General Secretary of the Central Committee on Research Involving Human Subjects (CCMO) to address concerns regarding clinical trial transparency within the country.

This initiative garnered support from various allied organizations, including Health Action International, Doctors Without Borders the Netherlands, Wemos, and TranspariMED.

The CCMO is currently undergoing the reform of the Dutch National Trial Registry. As health advocacy organizations, we are eager to contribute to this pivotal effort aimed at enhancing the prompt registration and reporting of results for all clinical trials conducted in the Netherlands and eagerly anticipate engaging in productive discussions with the CCMO….”

Rapid, accurate publication and dissemination of clinical trial results: benefits and challenges | European Heart Journal | Oxford Academic

Abstract:  Large-scale clinical trials are essential in cardiology and require rapid, accurate publication, and dissemination. Whereas conference presentations, press releases, and social media disseminate information quickly and often receive considerable coverage by mainstream and healthcare media, they lack detail, may emphasize selected data, and can be open to misinterpretation. Preprint servers speed access to research manuscripts while awaiting acceptance for publication by a journal, but these articles are not formally peer-reviewed and sometimes overstate the findings. Publication of trial results in a major journal is very demanding but the use of existing checklists can help accelerate the process. In case of rejection, procedures such as easing formatting requirements and possibly carrying over peer-review to other journals could speed resubmission. Secondary publications can help maximize benefits from clinical trials; publications of secondary endpoints and subgroup analyses further define treatment effects and the patient populations most likely to benefit. These rely on data access, and although data sharing is becoming more common, many challenges remain. Beyond publication in medical journals, there is a need for wider knowledge dissemination to maximize impact on clinical practice. This might be facilitated through plain language summary publications. Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians. This underscores the importance of ensuring that the information is understandable, accessible, balanced, and trustworthy. This report is based on discussions held on December 2021, at the 18th Global Cardiovascular Clinical Trialists meeting, involving a panel of editors of some of the top medical journals, as well as members of the lay press, industry, and clinical trialists.


NIHR tops international chart for clinical trial transparency | NIHR

“The NIHR has been recognised as the world’s most transparent research funding body.

New analysis produced by TranspariMED shows the NIHR is the only research funder in the world to have adopted all 11 of the World Health Organisation’s recommendations for maximising clinical trial transparency and minimising waste.

These include:

making all clinical trial results public within 12 months
having specific policies to prevent waste in research and speed up the development of new treatments
requiring researchers to make key data available on public trial registries and publish their results in scientific journals
monitoring whether researchers are following best practices, and sanctioning those that do not…”

Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials | BMJ Open

Abstract:  Objective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.

Design We used a dataset of trials registered in or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009–2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using ?2 or Fisher exact test.

Results In the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.

Conclusions Contrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals. is Modernizing to Serve You Better – NLM Musings from the Mezzanine

“ is the world’s largest database of privately and publicly funded clinical trials. It provides easy access to clinical trial information for millions of users every month—from patients and their advocates to data submitters, data researchers, and the broader public. NLM is in the midst of a multi-year effort to modernize to deliver an improved user experience on an updated platform that will accommodate future growth and enhance efficiency.

In June 2023, we will reach an important milestone: replacing the current website with the modernized website. This modernized site will implement the innovations we have designed based on user feedback, including an updated look and feel and improved functionality for searching, viewing, and downloading information about clinical trials….”

Peer reviewers from Low- and Middle-Income Countries(LMIC) for open access journals in oncology can improve the equity in cancer research and clinical trials. – ScienceDirect

“Open access journals(OAJ) in biomedicine are aimed to improve the reach and distribution of research and clinical trial publications. The publication in OAJ mode with article publishing charge(APC), in the oncology journals, are attracting and publishing the vast majority of papers from high-income countries(HIC). However, (a) there is great disparity in cancer care facilities and survival outcomes between high income and low-and middle-income countries(LMIC), (b) there is under-representation of publication of research and clinical trials, specific to cancers from LMIC, (c) OAJ in ‘oncology’ subject with APC are becoming unaffordable or have low contribution from LMIC. Unless proactive efforts are made, the OAJ and APC models would continue to miss the publication of clinical, basic, and outcomes data on cancers diagnosed and treated in LMIC regions. The cancer research and clinical trials which can bring to notice the challenges and hurdles faced by researchers, clinicians and cancer patients in LMIC will be served to some measure by engaging peer reviewers from those countries who are understanding the ecosystem. Peer reviewers from developing countries working for the open access oncology journals can increase the diversity in publication, thus nurturing a process of global equity in cancer management.”

Researchers Forget to Report How to Share Data From Studies Published in Spanish Medical Journals – ScienceDirect

“Some time ago, Archivos de Bronconeumología reported on a radical turnabout by the ICMJE: after announcing in 2016 that they would require clinical trial researchers to share individual-level anonymized participant data with third parties, in 2017 they decided that such transfer would be voluntary.4 The news had a precedent in the Recommendations published a few years earlier, to the effect that some journal editors “ask authors to say whether the study data are available to third parties to view and/or use/reanalyze, while still others encourage or require authors to share their data with others for review or reanalysis”.1 It would be interesting to know which Spanish journals have included this requirement in their ‘instructions for authors’ and whether they comply with it.

To answer this question, we reviewed the portals of 24 Spanish journals with an impact factor greater than 1, on the understanding that they have greater influence than those with an impact factor ?1 and those with no impact factor. Of these 24, 14 are included in the list of ICMJE Recommendations (Supplementary material A). Of these, only 5 (Archivos of Bronconeumología, Atención Primaria, Enfermedades Infecciosas y Microbiología Clínica, Gaceta Sanitaria, and Medicina Intensiva) include a specific section, that we shall call “link to data repository”, that recommends, supports and encourages authors to share raw data from their studies with other researchers, and gives instructions on how to go about it. A sixth journal, the Revista de Neurología, recommends this procedure only for clinical trials (Supplementary material B). To determine the frequency with which authors report how data can be accessed compared to other requirements requested by the same journals, 2 control requirements were selected: reporting on conflicts of interest and study funding, that were included in the Recommendations much earlier. It is also of interest to determine whether supplementary material may be included online, as this is sometimes a way of including raw study data….

Sharing data from quantitative studies is much easier than from qualitative studies. Researchers performing qualitative studies frequently cite the lack of authorization of the participants, the sensitive nature of the data, and loss of confidentiality as reasons for not sharing data.6 However, qualitative studies are the exception among Spanish medical publications. By 2011, most researchers were already sharing their data, although this was challenging for more than a third of them; in the case of clinical trials, it has recently been reported that access7 to data is difficult despite authors’ commitment to share.8 Ideally, Spanish medical journals should require authors to share them in all the articles they publish, and if data sharing is impossible, to explain why.”

Ten (not so) simple rules for clinical trial data-sharing | PLOS Computational Biology

Abstract:  Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing:

Rule 1: Abide by local legal and regulatory data protection requirements
Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding
Rule 3: Declare your intent to share data in the registration step
Rule 4: Involve research participants
Rule 5: Determine the method of data access
Rule 6: Remember there are several other elements to share
Rule 7: Do not proceed alone
Rule 8: Deploy optimal data management to ensure that the data shared is useful
Rule 9: Minimize risks
Rule 10: Strive for excellence.

Implementing clinical trial data sharing requires training a new generation of biomedical researchers | Nature Medicine

“Data sharing enhances the value of medical research and builds trust in clinical trials, but more biomedical researchers need to be trained in these approaches, which include meta-research, data science and ethical, legal and social issues….”

[Open letter to US FDA and NIH]

“I write regarding concerns about the lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the database. The law requires that certain clinical trial sponsors report results to to expand the knowledge base, support additional research, and provide important safety and efficacy information to health care providers and researchers. These important goals depend on adequate compliance with applicable requirements and appropriate enforcement.”

US congress committee calls for tougher action on trial sponsors who fail to meet reporting deadlines | The BMJ

“A US congress committee has criticised the Food and Drug Administration (FDA) and National Institutes of Health (NIH) for taking “only modest compliance action” against clinical trial sponsors who have not published results.1

Under US law, clinical trial sponsors are required to submit their results within one year of the completion date. Research looking at compliance in recent years found, however, that over 5000 trials were in “violation of applicable reporting requirements,”2 while over half (37 of 72) of reviewed trials that were funded by the NIH had failed to comply with applicable reporting requirements.3

The US Congressional Committee on Energy and Commerce has written to ask why the FDA and NIH have failed to sanction trial sponsors who break reporting rules….”

Mehr Transparenz in der klinischen Forschung: Wie werden die neuen Transparenzvorschriften aus Sicht der pharmazeutischen Industrie bewertet? | SpringerLink

[English-language abstract, article in German.]

Abstract:  The year 2014 was a turning point for transparency in clinical research. Two regulatory innovations comprehensively changed the rules in the EU. For one thing, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use (Clinical Trials Regulation – CTR) came into force, and for another thing, Policy 0070 of the European Medicines Agency (EMA) on the publication of and access to clinical data was published. While the policy has been occupying the pharmaceutical industry in practice since 2015, the requirements of the CTR came into effect at the end of January 2022.

The main innovation of the CTR is public access to the majority of documents and records that are created during the application process as well as during the course and after completion of a clinical trial. The special feature of Policy 0070 is the possibility for EU citizens to inspect the essential parts of a marketing authorisation application, such as the Clinical Study Report.

This contribution to the discussion describes the completely new challenges in the area of transparency that the pharmaceutical industry is facing as a result of the new requirements. In principle, transparency is to be welcomed in order to achieve the goals of the EU in the development and availability of medicines and vaccines. However, the protection of trade and business secrets of the pharmaceutical industry would be jeopardised. In the worst case, this could lead to a decline in investment in research and development within the scope of this regulation and to an international shift of clinical trials, including developing or emerging countries. Germany could lose more and more its leading role in conducting clinical trials in the EU.

Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles | Medical Journals and Publishing | JAMA Network Open | JAMA Network

Abstract:  Importance  Preprints have been widely adopted to enhance the timely dissemination of research across many scientific fields. Concerns remain that early, public access to preliminary medical research has the potential to propagate misleading or faulty research that has been conducted or interpreted in error.

Objective  To evaluate the concordance among study characteristics, results, and interpretations described in preprints of clinical studies posted to medRxiv that are subsequently published in peer-reviewed journals (preprint-journal article pairs).

Design, Setting, and Participants  This cross-sectional study assessed all preprints describing clinical studies that were initially posted to medRxiv in September 2020 and subsequently published in a peer-reviewed journal as of September 15, 2022.

Main Outcomes and Measures  For preprint-journal article pairs describing clinical trials, observational studies, and meta-analyses that measured health-related outcomes, the sample size, primary end points, corresponding results, and overarching conclusions were abstracted and compared. Sample size and results from primary end points were considered concordant if they had exact numerical equivalence.

Results  Among 1399 preprints first posted on medRxiv in September 2020, a total of 1077 (77.0%) had been published as of September 15, 2022, a median of 6 months (IQR, 3-8 months) after preprint posting. Of the 547 preprint-journal article pairs describing clinical trials, observational studies, or meta-analyses, 293 (53.6%) were related to COVID-19. Of the 535 pairs reporting sample sizes in both sources, 462 (86.4%) were concordant; 43 (58.9%) of the 73 pairs with discordant sample sizes had larger samples in the journal publication. There were 534 pairs (97.6%) with concordant and 13 pairs (2.4%) with discordant primary end points. Of the 535 pairs with numerical results for the primary end points, 434 (81.1%) had concordant primary end point results; 66 of the 101 discordant pairs (65.3%) had effect estimates that were in the same direction and were statistically consistent. Overall, 526 pairs (96.2%) had concordant study interpretations, including 82 of the 101 pairs (81.2%) with discordant primary end point results.

Conclusions and Relevance  Most clinical studies posted as preprints on medRxiv and subsequently published in peer-reviewed journals had concordant study characteristics, results, and final interpretations. With more than three-fourths of preprints published in journals within 24 months, these results may suggest that many preprints report findings that are consistent with the final peer-reviewed publications.