AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information (HHS — Notice)
United States · HHS 2026-08281
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
Technical 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
Who is protected: See Federal Register notice — auto-imported, specifics pending verification.
Who must comply: See Federal Register notice — auto-imported, specifics pending verification.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Status | Proposed / pending |
| Protection strength | Limited protection |
| Enacted | 2026-04-29 |
| Citation | HHS 2026-08281 |
| Enforced by | HHS |
| Topics | healthcare AI |
| Last verified | 2026-06-29 |
| Official source | Federal Register — HHS — 2026-08281 ↗ |
More AI rules in United States
- FTC Act Section 5 (unfair/deceptive AI) · In effect
- TAKE IT DOWN Act · In effect
- FCRA (AI in credit & background checks) · In effect
- ECOA / Regulation B (AI credit discrimination) · In effect
- Title VII / ADA (AI hiring) · In effect
- COPPA + 2025 Rule (childrens data) · In effect
Related healthcare AI rules elsewhere
- Colorado AI Act (repealed) · Repealed / replaced
- SB 26-189 (Colorado ADMT Law) · Enacted (not yet in effect)
- AI Companion Safeguards Law · In effect
- Utah AI Policy Act · In effect
- HB 452 (Mental Health Chatbots) · In effect
- My Health My Data Act · In effect
See something wrong or out of date? Submit a correction — every entry must carry a verifiable official source.