FDA Implements Modernized Clinical Trial Standards with E6(R3) GCP.

The FDA has released draft guidance with updated recommendations for good clinical practices (GCPs) to modernize the design and conduct of clinical trials, making them more efficient and flexible without compromising data integrity or participant protections. The draft guidance is aimed at incorporating rapidly developing technological and methodological innovations into the clinical trial enterprise and encouraging the use of innovative trial designs and health technologies. The FDA is requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial types and data sources.