2026-08281
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information (HHS — Notice)
United States · HHS 2026-08281
- Status
- Proposed / pending
- Applies to
- See Federal Register notice — auto-imported, specifics pending verification.
- Enforced by
- HHS
The Food and Drug Administration (FDA or the Agency) is issuing this request for information 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. Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision- making processes. This pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance
Who is protected: See Federal Register notice — auto-imported, specifics pending verification.
Legal detail
The Food and Drug Administration (FDA or the Agency) is issuing this request for information 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. Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision- making processes. This 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 pilot program will be guided by principles aligned with the National Institute of Standards and Technology (NI
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Enacted | April 29, 2026 |
| Citation | HHS 2026-08281 |
| Topics | healthcare AI |
| Agency page | Federal Register — HHS — 2026-08281 |
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