AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Informat
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 tr
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-04-29 |
| Summary | 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 dec |
| Document number | 2026-08281 |
| Official record | https://www.federalregister.gov/documents/2026/04/29/2026-08281/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information |