Save the Date – May 17th “Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?”

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

LOCATION:  Wasserstein Hall, Milstein West A, Harvard Law School

1585 Massachusetts Avenue, Cambridge, MA

Speakers and registration information to be announced shortly

May 17, 2013 (8AM – 6PM)

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

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