Comment Letter on FDA AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program

The Duke-Robert J. Margolis, MD Institute for Health Policy (“Duke-Margolis” or the “Institute”) appreciates the opportunity to provide comments on the U.S. Food and Drug Administration’s (FDA) request: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information. We are encouraged by the FDA’s commitment to advancing evidence generation, including using real-world data (RWD) and real-world evidence (RWE).

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