FDA Proposes Clinical Data Disclosure; Argues Sharing Will Improve Trial Design

The agency suggests making masked clinical trial data available to outside parties for further analysis, saying access may enable researchers to overcome drug development hurdles, such as identification of primary endpoints or potential biomarkers.

Following the path of the European Medicines Agency, FDA is proposing to make clinical trial data available to outside parties for further analysis. The move will put increasing pressure on the pharmaceutical industry to provide more detailed trial data to the public.

In a Federal Register notice slated for publication June 4, FDA calls for public comments on its proposal...