2025 CRDSA Summit: Data Reuse – Navigating the Regulatory Environment

The second day of CRDSA’s 2025 Summit summit was all about the European data space, covering EHDS, various IHI projects, Darwin, and more. Sessions addressed how the initiatives work together (and where they don’t), with a focus on the role of industry, both as data providers and data users.

• Demystifying the EU Data Space   (Keynote)
• EHDS: What’s in store for the European Health Data Space  (Presentation)
• Individual Patient Data Sharing in the EU  (Panel Discussion)

Drawing from their unique perspectives, CRDSA’s board members discuss the foundational elements needed to support a data reuse ecosystem that best serves patients, accelerates drug discovery, and advances human health.

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.