The Yale University Open Data Access (YODA) Project requested public comment on the policy and procedures that guide the process used to make clinical trial data available, including both Clinical Study Reports and participant-level data. These comments are available below.
The policy and procedures were informed by the following:
- The YODA Project’s prior experience with sharing Medtronic’s participant-level clinical trial data for recombinant human bone morphogenetic protein-2 (rhBMP-2);
- Recommendations from the YODA Project Steering Committee, an independent group of leaders in the fields of clinical research and biomedical ethics convened by the YODA Project to provide guidance;
- Recommendations from other experts, stakeholders, and industry partners; and
- The YODA Project’s review of the literature and policies from other bodies engaged in clinical trial data sharing.
All public comments were taken into consideration, but incorporated at the discretion of the YODA Project. The YODA Project seeks to continually improve these policies and, accordingly, may modify the policy in the future.
More information can be found via the links below: