Institute of Medicine Maps Out Clinical Trial Data Sharing Program

23rd January 2015

Investigators and sponsors of clinical trials will have to make more detailed data available following study completion, according to a new report from an Institute of Medicine expert panel, but they will have several months to disclose individual case reports and complete data supporting registration applications. Just what data will be shared, with whom and under what terms will be specified in a data-sharing plan that sponsors will submit when they register a study on a public website.

Industry has been under increased pressure in both Europe and the U.S. to make public extensive detailed information collected during clinical trials, and the IOM advisors have produced a compromise approach that supports broad, routine data sharing, while also protecting the rights of multiple stakeholders. Data sharing is important for encouraging further research, supporting regulatory decisions, and increasing public trust in clinical research, said Bernard Lo, president of The Greenwall Foundation, who chaired the IOM committee. The main goal, he observed, is that the sharing of clinical trial data should become “the expected norm.”

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