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Data sharing in stepped-wedge cluster randomized trials: suboptimal data availability despite "data available upon
Cory E Goldstein1, Anna Catharina V Armond2, Kelly D Cobey2
1Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa Ontario, Canada.
Journal of Clinical Epidemiology
|June 4, 2026
Summary
Data sharing statements in stepped-wedge cluster randomized trials (SW-CRTs) do not guarantee data access. Actual data obtainment rates are low, with regional variations influencing success, highlighting a need for better data sharing guidance.
Area of Science:
- Health Research Methodology
- Biostatistics
- Clinical Trials
Background:
- Data sharing is crucial for research transparency, reproducibility, and innovation.
- Access to real-world trial data is essential for statistical method development and validation.
Purpose of the Study:
- To assess the prevalence and types of data sharing statements in published stepped-wedge cluster randomized trials (SW-CRTs).
- To determine the actual availability of SW-CRT datasets upon author request.
- To identify factors associated with successful data obtainment.
Main Methods:
- Identified SW-CRTs published between 2016-2023.
- Classified data sharing statements (publicly available, available upon request, not available).
- Emailed authors to request datasets and analyzed factors associated with data obtainment using logistic regression.
Main Results:
- Only 45% of SW-CRTs had clear data sharing statements; 35% of datasets were obtained.
- Data obtainment rates did not differ between studies with no statement and those available upon request.
- Trials in low- and middle-income countries showed higher odds of data obtainment (OR=2.9).
Conclusions:
- Data sharing practices in SW-CRTs are suboptimal, with statements not reflecting actual data availability.
- Regional variations significantly impact data obtainment, while other trial characteristics have limited influence.
- Improved guidance and resources are necessary to facilitate effective data sharing in health research.
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