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Christof Manuel Schönenberger, Alexandra Griessbach, Ala Taji Heravi, Dmitry Gryaznov, Viktoria L. Gloy, Szimonetta Lohner, Katharina Klatte, Nilabh Ghosh, et al.
(2022).
A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols.
Journal of Clinical Epidemiology, 149, 45-52.
Elsevier BV.
- Publication date
-
September 2022
- Identifier
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10.1016/j.jclinepi.2022.05.014
- Authors
-
Christof Manuel Schönenberger,
Alexandra Griessbach,
Ala Taji Heravi,
Dmitry Gryaznov,
Viktoria L. Gloy,
Szimonetta Lohner,
Katharina Klatte,
Nilabh Ghosh,
Hopin Lee,
Anita Mansouri,
Ioana R. Marian,
Ramon Saccilotto,
Edris Nury,
Jason W. Busse,
Belinda von Niederhäusern,
Dominik Mertz,
Anette Blümle,
Ayodele Odutayo,
Sally Hopewell,
Benjamin Speich,
Matthias Briel
- Source
- Journal of Clinical Epidemiology
- Details
- 149, 45-52
- Reference type
- article
- Publisher
- Elsevier BV
- Metadata source
- crossref
Abstract
OBJECTIVES: Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency. STUDY DESIGN AND SETTING: In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability. RESULTS: Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results. CONCLUSION: RCT protocols should be made available at an early stage of the trial.
Study authors in this cited reference