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Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study
Enrique Vazquez1, Joseph S Ross2,3,4, Cary P Gross2,5,6
1Yale University, New Haven, CT, USA.
Clinical Trials (London, England)
|May 21, 2025
Summary
Clinical trial data sharing proposals frequently do not match their published results. Researchers should detail deviations, and platforms should improve reporting for better transparency in data reuse.
Area of Science:
- Clinical research
- Data science
- Biostatistics
Background:
- Clinical trial data sharing has increased, with platforms requiring proposals for data access.
- Evaluating the alignment between proposals and publications is crucial for data integrity.
Purpose of the Study:
- To assess the concordance between clinical trial data use request proposals and their corresponding publications across four major data-sharing platforms.
- To identify discrepancies in requested trials, study objectives, endpoints, and statistical methods.
Main Methods:
- Analyzed publication-request pairs from Vivli, ClinicalStudyDataRequest.com, Yale Open Data Access Project, and Supporting Open Access to Researchers-Bristol Myers Squibb (as of March 2023).
- Classified concordance for trials, objectives, and statistical methods as fully concordant, partially concordant, discordant, or unclear.
- Endpoint concordance was assessed for the Yale Open Data Access Project due to data reporting variations.
Main Results:
- Concordance varied significantly across platforms and characteristics.
- For Vivli, 29.9% of pairs were fully concordant across reported characteristics; for ClinicalStudyDataRequest.com, 18.9%; for Yale, 23.1%; and for Bristol Myers Squibb, 33.3%.
- Overall, only about 25% of proposals fully matched publications across key reported elements.
Conclusions:
- Significant discordance exists between clinical trial data sharing proposals and published outcomes.
- Investigators should transparently report deviations from proposals in publications.
- Data-sharing platforms can improve reporting standards to enhance the clarity and reliability of data reuse.
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