Responsible Data-Sharing for Clinical Trials

Friday, 13 February 2015: 3:00 PM-4:30 PM
Room 210EF (San Jose Convention Center)
An Institute of Medicine committee is conducting a consensus study to develop guiding principles and a framework of activities and strategies for the responsible sharing of clinical trial data. For the purposes of the study report, the scope is limited to interventional clinical trials, and “data sharing” will include the responsible entity (data generator) making the data available via open or restricted access, or exchanged among parties. For the purposes of this study, data generators will include industry sponsors, data repositories, and researchers conducting clinical trials. Specifically, the committee will articulate guiding principles that underpin the responsible sharing of clinical trial data and describe a selected set of data and data-sharing activities; identify key benefits of sharing and risks of not sharing; address key challenges and risks of sharing -- e.g., resource constraints, implementation, disincentives in the academic research model, changing norms, protection of human subjects and patient privacy, intellectual property/legal issues, preservation of scientific standards, and data quality; and outline strategies and suggest practical approaches to facilitate responsible data sharing. This session will review the committee's work on the study.
David L. DeMets, University of Wisconsin
Bernard Lo, Greenwall Foundation
Steve Goodman, Stanford University School of Medicine
Uses and Misuses of Shared Clinical Trial Data
Ida Sim, School of Medicine, University of California, San Francisco
Technical Challenges in Sharing Clinical Trial Data
Timothy Coetzee, National Multiple Sclerosis Society
Stakeholders in the Proposed Data-Sharing Policy