A new report from the Institute of Medicine (IOM) provides recommended guidelines about what data should be shared at key times in a clinical trial. In its report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, an IOM committee concludes that sharing data is in the public interest, but a multistakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing.
Because no authority currently exists to enforce the report’s recommendations, the IOM recommended that the 23 sponsors of the study—including the National Institutes of Health, the U.S. Food and Drug Administration, several pharmaceutical and biotechnology companies, and charitable organizations—convene a multistakeholder body to address challenges associated with sharing clinical trial data.
More information on the report can be found at www.nap.edu/catalog/18998/sharing-clinical-trial-data-maximizing-benefits-minimizing-risk. ■
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