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Clinical trial data sharing: here's the challenge
Sonali Kochhar1,2, Bartha Knoppers3, Carrol Gamble4
1Global Healthcare Consulting, New Delhi, India.
BMJ Open
|August 24, 2019
Summary
Patient data sharing platforms like Clinical Study Data Request (CSDR) show low demand and publication rates, questioning the sustainability of current models for clinical research data access. Addressing barriers for researchers and data contributors is crucial for realizing the full potential of shared health data.
Area of Science:
- Clinical research
- Data science
- Health informatics
Background:
- Anonymised patient-level data is valuable for advancing scientific research and improving patient care.
- Responsible data sharing requires effective systems for all stakeholders.
- The Clinical Study Data Request (CSDR) platform aims to facilitate access to clinical research data.
Purpose of the Study:
- To present summary metrics from the CSDR platform.
- To investigate the observed low demand for shared clinical research data.
- To challenge the research community regarding the utilization of shared data.
Main Methods:
- Analysis of data from the CSDR platform between 2014 and January 2019.
- Review of research proposals (RPs) submitted, approved, and leading to publications.
- Assessment of platform metrics including application numbers and publication rates.
Main Results:
- 473 research proposals submitted, 291 approved by the Independent Review Panel (IRP).
- Only 41 publications reported from 90 completed analyses by January 2018.
- Less than half of studies listed on CSDR have been requested, indicating low engagement.
Conclusions:
- The low number of applications and resulting publications challenge the sustainability of the CSDR model.
- Barriers for data contributors and secondary analysis researchers need identification and resolution.
- Sustainable data sharing models are essential to unlock the full potential of shared clinical data for knowledge advancement and patient health.
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