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Session 5: Disclosing Participant-level Data: Goals and Challenges
Session Chair(s)
Patricia Teden, MBA
President and Principal
Teden Consulting LLC, United States
The EMA has stated their intent to make participant-level datasets for clinical trials studying products approved in the EU available to the public by January 2014. Draft policies and processes should be available by conference time. The U.S. Office of Science and Technology Policy recently asked federal agencies that fund more than $100 million in research annually to craft proposals for disclosing results (publications, datasets) of federally-funded research to the public. This session will explore the goals and challenges of sharing granular data with the public, e.g., participant-level data from clinical trials.
Speaker(s)
Multi-Regional Clinical Trials (MRCT) Center Data Sharing Working Group
Rebecca Li, PHD
Vivli , United States
Executive Director, Center for Global Clinical Research Data
“Yale Open Data Access” (YODA)
Joseph Ross, MD, MHS
Yale University School of Medicine, United States
Professor of Medicine and Public Health
Data Sharing in a World Firmly Rooted in Journal Publications: the RIAT Concept
Peter Doshi, PHD
Johns Hopkins University School of Medicine, United States
Postdoctoral Fellow in CER Divisions of Gen Pediatrics & Gen Internal Medicine
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