Comment from Academy of Managed Care Pharmacy (AMCP)
AnonymousSupportAdvocacy
Summary: The Academy of Managed Care Pharmacy (AMCP) supports the FDA's pilot program for using AI to optimize early-phase clinical trials, provided it prioritizes human-in-the-loop decision support and high-impact, lower-risk applications like trial design. They recommend specific frameworks for risk classification, data governance, and transparency to ensure that AI improves scientific quality and efficiency without compromising participant safety or human accountability.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the Request for Information: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Please see attached for AMCP's full comments.