Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development

Lexology April 19, 2024
Hogan Lovells

The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at enhancing clinical trial innovation for drug development and regulatory decision-making. The establishment of the center is part of FDA’s broader efforts in fostering clinical trial innovation. More specifically, C3TI will serve as a nerve center for facilitating the sharing of important innovative lessons and insights across CDER’s other existing programs and communicating those lessons with external parties.

C3TI’s demonstration program is open to sponsors with active investigational drug developmental programs in the project areas of 1) point-of-care or pragmatic trials, 2) trials implementing Bayesian...

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