FDA to Put Almost $38 Million Behind Effort to Improve Clinical Trials

In a 22 May 2014 Federal Register announcement, FDA said it plans to grant the Duke Translational Medicine Institute (DTMI) $7,500,000 per year for as many as five years in the hopes that the “clinical trial enterprise” can be improved to better provide regulators and industry with data to drive decision-making.  The funding will principally go toward helping the Clinical Trials Transformation Initiative (CTTI) increase the quality and efficiency of clinical trials,” FDA said.

CTTI, which is based out of Duke University, includes nearly every major government healthcare agency, pharmaceutical company and trade group as members, as well as several medical device manufacturers and academic medical centers.  The group’s stated goal is to “identify and promote practices that will increase the quality and efficiency of clinical trials,” which it does by identifying specific problems, and then establishing projects to study the issue and propose solutions.  The broader intent of the CTTI is to find solutions to common problems, which any one company or entity would ordinarily find prohibitively expensive.  “The opportunity for meaningful interaction with a broad set of stakeholders committed to improving the clinical trial enterprise and also the ability to rapidly gather data to address emerging issues offer significant value to the clinical trial enterprise,” wrote FDA, a CTTI member, in its Register notice.
REFERENCE:  Regulatory Focus; Alexander Gaffney, RAC; 22 MAY 2014

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