The Institute of Medicine is soliciting public comment on how best to responsibly share data from clinical trials.
IOM has issued a discussion framework that includes preliminary guiding principles, defined selected data, data sharing activities and specific questions for researchers, clinical trial sponsors, patients, advocacy organizations and the general public.
Clinical trials of medical interventions such as drugs, medical devices, procedures and behavioral interventions generate vast amounts of data, which might be shared confidentiality with government regulatory agencies or other parties but are not routinely available to other researchers or the public, IOM notes in a statement. Sharing these data more broadly--while respecting research participants and their privacy--could facilitate new analyses, provide a deeper understanding of therapies, and ultimately provide a sounder basis for clinical care.
The discussion framework is available here. Comments can be submitted here and are most useful if sent by March 24, 2014. IOM expects to release a final report with findings and recommendations in late 2014.
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