FDA Launches the Center for Clinical Trial Innovation

Lexology June 14, 2024
Jones Day

Building on CDER’s efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct.

In April 2024, the U.S. Food and Drug Administration (“FDA”) Center for Drug Evaluation and Research (“CDER”) announced the launch of the Center for Clinical Trial Innovation (“C3TI”) to support innovative approaches to clinical trials designed to improve drug development efficiency through enhanced communication and collaboration.

C3TI will primarily serve as a “central hub” to:

• Facilitate sharing of lessons learned across CDER’s existing clinical trial innovation programs.
• Serve as the single CDER point of contact to support non-product-specific questions about clinical trial innovation.
• Support knowledge-sharing through discussion forums, public workshops, communications, and a knowledge repository consolidating information on CDER’s clinical...

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