What: On April 29, 2026, the U.S. Food and Drug Administration (FDA) published a Request for Information (RFI) to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials.
Why: The FDA’s pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed) while maintaining FDA’s rigorous scientific and regulatory standards and promoting trustworthy AI systems. The FDA seeks input on how to structure the pilot to maximize learning, feasibility, and impact. Specifically, the RFI seeks comments on scope and focus, participant selection, collaboration models, operational structure, timeline and milestones, and knowledge sharing.
The FDA also seeks input on appropriate metrics and approaches to evaluate the pilot program, including:
- Qualitative Outcomes
- Trial Efficiency and Speed
- Decision Quality
- Participant Safety and Data Integrity
- AI System Performance
- Trustworthiness
- Comparative Evaluation
Action: Review the RFI and submit comments before the May 29, 2026, deadline.
RFI:
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
CONTACT:
Will Purcell
EMAIL:
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