Online Program

Return to main conference page
Thursday, September 13
Thu, Sep 13, 5:45 PM - 6:45 PM
Thurgood Marshall East
Late Breaking Session: Data Sharing in Clinical Research: Challenges and Opportunities

Clinical Trial Open Data Access: Where are we on the Transparency Journey? (300806)

*Frank W Rockhold, Duke University Medical Center 

Calls for greater transparency and “open data access” in clinical research have been widespread for a number of years, from many sources including the Executive Office of the President, which in 2013 called for increased access to the results of federally funded research. In 2015, The Institute of Medicine issued a report advocating for a multi-stakeholder effort to foster responsible data sharing, and there are many others. In 2016 both FDA and NIH issued their final rules on data disclosure. The discussion and debate has accelerated in 2017 to include a new ICMJE proposal and a National Library of Medicine Consensus conference. Open access is good for innovation for future patients, honors clinical trial participants and a valuable resource for researchers. The question at the center of open-science efforts for clinical trials is no longer whether data should be available for access, but rather how we can usher in responsible methods for doing so. In spite of that, there remain some real and perceived barriers to doing so, such as patient privacy, data standards, commercial concerns, academic credit, etc. This talk reviews the history and current status of data disclosure efforts, challenges and solutions to achieving transparency, and suggestions for the future.