IOM to Issue Discussion Framework on Clinical Trial Data Sharing


Clinical trials of drugs, medical devices, vaccines, and other health interventions generate vast amounts of data that are provided confidentially to regulatory agencies, but much of these data remain largely unavailable to other researchers or the public.  Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, from an Institute of Medicine study committee that is examining  how to share data from clinical trials responsibly, provides the committee's preliminary guiding principles, defines and describes select data-sharing activities, and poses key questions to solicit public input from researchers, agencies that sponsor research, patients, advocacy groups, other stakeholders, and the public.   The input will be used to help the study committee develop findings and recommendations for its final report, expected at the end of the year.



Advance copies will be available to reporters only beginning at 1 p.m. EST Tuesday, Jan. 21. The report is embargoed and not for public release before 11 a.m. EST Wednesday, Jan. 22. To obtain an embargoed copy, contact the National Academies' Office of News and Public Information; tel. 202-334-2138 or e-mail