Data sharing statements for clinical trials: a cross-sectional survey of cardiology journals

Abstract

Objective: The International Committee of Medical Journal Editors requires data sharing statements in trial publications, but whether cardiology journals request data sharing statements in clinical trial submissions is unclear. We performed a survey to assess whether cardiology journals request data sharing statements in clinical trials.

Design, setting, data source and participants: All cardiac and cardiovascular systems journals that published clinical trials from January 2019 to December 2022 were included. The study outcome was journal requests for data sharing statements. Multivariable logistic regression analysis was used to examine the association between journal characteristics and journal requests. We also explored whether journal requests aligned with their subsequently published clinical trials.

Results: A total of 126 journals were included, among which 96 (76.2%) requested data sharing statements in clinical trials. Elsevier journals and Consolidated Standards of Reporting Trials endorsement had increased adjusted odds of requesting data sharing statements, with an OR of 5.74 (95% CI 1.45 to 22.70) and 7.21 (2.69 to 19.32), respectively. In the 78 journals that requested statements, 24 (30.8%) indeed did not publish any data sharing statement in their trial reports.

Conclusions: Approximately one in four cardiology journals did not request data sharing statements on clinical trial submissions, while a substantial inconsistency existed between journal requests and the actual publications of statements in their published trial reports.

Keywords: CARDIOLOGY; Clinical Trial; Health informatics; Surveys and Questionnaires.

Figure 1. Flow diagram showing the selection of journals for this study. CVD, cardiovascular disease; ESCI, Emerging Sources Citation Index; IPD, individual participant data; SCI: Science Citation Index Expanded.

Figure 2. Multivariable logistic regression analysis results for the association between journal characteristics and request for data sharing statements. CONSORT, Consolidated Standards of Reporting Trials; ICMJE, International Committee of Medical Journal Editors.

Figure 3. Comparison between journals publishing any data sharing statement in their published clinical trial reports and journal request for data sharing statements identified from their submission guidance webpages.