Background: The transparency of clinical trial data, specifically Clinical Study Reports (CSRs) and Individual Participant Data (IPD), is essential for building trust in drug approval processes, preventing study duplications, and informing future trials. Organizations such as the World Health Organization, Cochrane, and the European Medicines Agency advocate for independent access to these data to enhance scientific discovery and clinical practice.
Methods: A comprehensive review was conducted to evaluate recent policy changes, current status, and future opportunities for CSR and IPD sharing, with a focus on industry-sponsored oncology trials. We analysed published cross-sectional studies that examined trials cited in FDA-approved drug labels. Additionally, we reviewed current policies of major pharmaceutical companies and regulatory agencies regarding CSR and IPD sharing.
Results: Policy changes by the EMA and Health Canada have facilitated the sharing of CSRs, yet operational challenges remain. Analysis of cross-sectional studies revealed that 35% of CSRs were publicly accessible through regulatory portals and 21% were available upon request from sponsors. 44% of CSRs remain inaccessible. For IPD, 45% of trials were eligible for data requests, but data was provided for only 77% of eligible trials. The median time to data provision was 123 days, with significant variability in data completeness. Overall, IPD was acquired from only 34% of trials - highlighting the risk of bias in systematic reviews relying on limited data.
Recommendations: To address these challenges, it is recommended to standardize CSR and IPD sharing policies, ensure immediate data availability upon drug approval, and employ independent panels for IPD request reviews. Comprehensive data sharing can facilitate practice-changing findings, improve systematic reviews, and enhance personalized patient care. Stakeholders, including regulatory bodies, journals, and the pharmaceutical industry, must collaborate to implement policies that promote transparency and maximize the potential for scientific discovery.