Federal Register #2026-10602

FDA Request for Information: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public input on a pilot program for AI-enabled optimization of early-phase clinical trials. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Purpose: - Request for Information (RFI) to gather stakeholder feedback on using artificial intelligence (AI) technologies to improve early-phase clinical trials - Focus on enhancing efficiency, speed, and quality of decision-making in clinical research - Products/Services Requested: - No specific products or services are being procured - The RFI is for information gathering only; no purchases or contracts will be awarded at this stage - OEMs and Vendors: - No OEMs or vendors are named in the notice - Unique or Notable Requirements: - Seeks public comments and insights on the integration of AI in clinical trials - Open to input from a wide range of stakeholders, including industry, academia, and technology developers

Description

The Food and Drug Administration (FDA) is extending the comment period for a request for information regarding 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. The extension allows interested persons additional time to submit comments. Comments must be submitted by June 29, 2026. The FDA is seeking input to better understand the potential benefits and challenges of integrating AI in early-phase clinical trials.

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