GEN | News Highlights:Data Sharing Takes Two Steps Forward

"Two small but significant steps forward were taken yesterday in the direction of open access to clinical trial data. A committee of the Institute of Medicine (IOM) yesterday called for the sharing of supporting data for clinical trials results within six months after publication, with a full analyzable data set shared no later than 18 months after study completion or 30 days after regulatory approval. Also yesterday, Johnson & Johnson (J&J) joined the Yale Open Data Access (YODA) Project in agreeing to share data from clinical trials for medical devices and diagnostics. The YODA Project said in a statement that the agreement 'establishes a fully independent intermediary to manage requests and promote data use,' as J&J has done with pharmaceutical clinical trial data since last year. Under the agreement, the YODA Project will approve or deny requests from investigators for de-identified patient data associated with the pharmaceutical, medical device, and diagnostic clinical trials conducted by J&J companies ..."