US FDA considering making "masked" trial data available to outside experts

According to a Federal Register posting, the US Food and Drug Administration is seeking public comments from interested persons on the proposed availability of “deidentified” and “masked” data derived from medical product applications.

The FDA says that improving the efficiency and development is a national priority. The ability to make available de-identified and masked clinical and preclinical data derived from marketing applications could make an important contribution to that goal by providing scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products. The contribution of patients who participate in clinical trials should be maximized for the benefit of society.

FDA inviting comment