In this original investigation, Dr. Ashley Hopkins (Flinders University) and colleagues, including Frank Rockhold (Duke CRI and CRDSA Board Director) and Aaron Mann (CRDSA), address the utility and completeness of individual-participant data (IPD) and the supporting documents provided from industry-sponsored clinical trials. The study includes IPD packages received from 70 of 91 eligible clinical oncology trials (77%) for a planned meta-analysis. The analysis indicated substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

Date: October 5, 2023

Content Type: General Resources

Work Group: Articles