Harvard University’s Multi-Regional Clinical Trials Center (MRCT) submitted the following comments on FDA’s proposal, 78 Fed. Reg. 33421 (June 4, 2013), to make de-identified and masked clinical and preclinical data, from marketing applications submitted to FDA, available to external experts and others, as part of the Agency’s transparency initiative.
FDA proposes to make available to the public pooled data that have been sufficiently de-identified and masked (as to the drugs involved in the trial) in order to protect confidential commercial information, for analysis by the broader community.
The Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions Conference, held on May 17th, 2013, drew close to 200 participants and proved to be an exceptional platform to discuss matters surrounding clinical trial data sharing.
Harvard MRCT is grateful to all the Conference Speakers, Panelists, and attendees who made this a stimulating and productive day.
