Comment from Duke-Margolis Institute for Health Policy
AnonymousSupportAcademic
Summary: The Duke-Margolis Institute for Health Policy supports the FDA's pilot program to use AI for optimizing early-phase clinical trials, praising the agency's commitment to advancing evidence generation. They provide constructive feedback on prioritizing generalizable results, managing the compressed timeline, and balancing AI-driven speed with rigorous risk-benefit frameworks.
To whom it may concern,
Please find our detailed comments attached on behalf of the Duke-Margolis Institute for Health Policy and in response to FDA's request for information regarding "AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information."
Sincerely,
Dr. Rachele Hendricks-Sturrup