Journal requirement for data sharing statements in clinical trials: a cross-sectional study

Objective Data sharing statements are considered routine in clinical trial reporting, and represent a step towards data transparency. The International Committee of Medical Journal Editors (ICMJE) require clinical trials to publish data sharing statements. To assess requirement for data sharing statements by biomedical journals, and to explore associations between journal characteristics and requirement for data sharing statements. Study Design and Setting In this cross-sectional study, we included all biomedical journals that published clinical trials from January 1st, 2019 to December 31st, 2022 and that were indexed by the Journal Citation Reports. The study outcome was the journal requirement for data sharing statements. Multivariable logistic regression analyses were used to assess the relationship between journal characteristics and requirement for data sharing statements. Results Of the 3,229 biomedical journals included in the analyses, 2,345 (72.6%) required authors to include data sharing statements. Journals published in the UK (OR, 3.19 [95% CI, 2.43 to 4.22]) and endorsing the Consolidated Standards of Reporting Trials (CONSORT) (OR, 3.30 [95% CI, 2.78 to 3.92]) had greater odds of requiring data sharing statements. Journals that were Open Access, non-English language, in the Journal Citation Reports group of clinical medicine, and on the ICMJE list had lower odds of requiring data sharing statements, with ORs ranging from 0.18 to 0.81. Conclusion Despite ICMJE recommendations, more than 27% of biomedical journals do not require clinical trials to include data sharing statements, highlighting room for improved transparency.