Please save the date for this upcoming conference at Harvard Law School on May 17, 2013:

Issues and Case Studies in Clinical Trial Data Sharing:

What Have We Learned?

Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

Objectives:

To discuss opportunities for and implications of emerging clinical trial data disclosure standards
To review evidence from recent case studies in clinical trial data disclosure, especially related to disclosure of participant-level data
To review the rationale behind disclosure requirements of patient-level data and discuss whether the case studies demonstrate the goals have been met
To identify potential areas of collaboration among stakeholder groups, such as the formation of working groups to provide recommendations or standards in this area
To review variance in regulatory approaches and areas for possible harmonization
To identify other key areas of learning that may inform policy in this important area moving forward
To use conference findings as basis of a publication in a peer-reviewed journal that captures the case studies, provides insights into these issues and offers recommendations for moving forward