FDA Requests Input on Proposed AI-Enabled Early-Phase Clinical Trials Pilot Program
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Summary
Food and Drug Administration issued a notice and request for information seeking input on a proposed pilot program to assess how AI-enabled technologies can improve efficiency, speed and quality of decision-making in early-phase clinical trials. The pilot would explore trial efficiency, safety monitoring, dose selection and early go/no-go decisions, guided by principles aligned with the NIST AI Risk Management Framework. It would recruit sponsors pursuing early-phase trials through product applications to several FDA centers and be coordinated by the Deputy Chief Medical Officer. The notice poses questions on pilot design, participant selection, timelines, evaluation metrics and trustworthiness. Comments are due by May 29, 2026.
Why it matters
The notice gives sponsors, technology vendors, investigators and other stakeholders a chance to shape a proposed FDA pilot on AI use in early-phase drug trials. It signals that FDA would apply considerations from its draft guidance on AI in regulatory decision-making. Comments must be received by May 29, 2026.
- Parties involved
- Food and Drug Administration; Department of Health and Human Services
- Federal Register doc. no.
- 2026-08281
- Citation
- 91 FR 23100
- Docket number
- FDA-2026-N-4390
- Primary source
- Federal Register (US) (federalregister.gov)
Source retrieved: . Sources are often in other languages; links open the original. - Topics
- Healthcare & medical AI · General AI governance