Transparency and reporting characteristics of COVID-19 randomized controlled trials
Open accessPublished version of a preprint
Abstract
Background: In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all preprints subsequently published in peer-reviewed journals. Methods: We searched the Cochrane COVID-19 Study Register and L·OVE COVID-19 platform to identify all reports of RCTs assessing pharmacological treatments of COVID-19, up to May 2021. We extracted indicators of transparency (e.g., trial registration, data sharing intentions) and assessed the completeness of reporting (i.e., some important CONSORT items, conflict of interest, ethical approval) using a standardized data extraction form. We also identified paired reports published in preprint and peer-reviewed publications. Results: We identified 251 trial reports: 121 (48%) were first published in peer-reviewed journals, and 130 (52%) were first published as preprints. Transparency was poor. About half of trials were prospectively registered ( n = 140, 56%); 38% ( n = 95) made their full protocols available, and 29% ( n = 72) provided access to their statistical analysis plan report. A data sharing statement was reported in 68% ( n = 170) of the reports of which 91% stated their willingness to share. Completeness of reporting was low: only 32% ( n = 81) of trials completely defined the pre-specified primary outcome measures; 57% ( n = 143) reported the process of allocation concealment. Overall, 51% ( n = 127) adequately reported the results for the primary outcomes while only 14% ( n = 36) of trials adequately described harms. Primary outcome(s) reported in trial registries and published reports were inconsistent in 49% ( n = 104) of trials; of them, only 15% ( n = 16) disclosed outcome switching in the report. There were no major differences between preprints and peer-reviewed publications. Of the 130 RCTs published as preprints, 78 were subsequently published in a peer-reviewed journal. There was no major improvement after the journal peer review process for most items. Conclusions: Transparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient both in preprints and peer-reviewed publications. A comparison of paired reports published in preprint and peer-reviewed publication did not indicate major improvement.
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- Authors
- Kapp, P., Esmail, L., Ghosn, L., Ravaud, P., & Boutron, I.
- Affiliations
- Conservatoire National des Arts et Métiers (FR)
- Corresponding author
- Boutron, Isabelle
- Venue
- BMC Medicine
- Published
- 2022-09-26
- Volume
- 20
- Issue
- 1
- Pages
- 363-363
- ISSN
- 1741-7015 (ISSN-L)
- PMC
- PMC9510360
- OpenAlex
- W4297144044
- Cited by
- 25
- References
- 55
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 8 · 2023: 7 · 2022: 2
- FWCI
- 4.81
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Medicine (publishedVersion, cc-by)
- medRxiv (acceptedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Université Paris Descartes
- Assistance Publique - Hôpitaux de Paris
- Institut national de la santé et de la recherche médicale
- Cochrane France
- Ministère de l’Enseignement Supérieur, de la Recherche Scientifique et des Technologies de l'Information et de la Communication
- Agence Nationale de la Recherche
- The World Health Organization
- Topics
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Keywords
- COVID-19 pandemic, randomized controlled trials, trial reporting quality, preprints, peer review, clinical trial registration, CONSORT, data sharing, allocation concealment, conflicts of interest, harms reporting, pharmacotherapy, transparency, reporting completeness, reporting consistency, clinical trial registries, statistical analysis plan, primary outcomes
- MeSH terms
- COVID-19, Humans, Peer Review, Randomized Controlled Trials as Topic, Information Dissemination, Research Report
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