Premier Weighs in with FDA on AI-Enabled Clinical Trials Pilot

Premier submitted comments to the FDA in response to its request for information (RFI) on an AI-enabled pilot program to optimize early-phase clinical trials. In its letter, Premier expressed support for the pilot as an opportunity to improve trial efficiency, reduce costs and timelines, and expand patient access while emphasizing the need for clear safeguards, regulatory certainty, and patient-centered design. Premier also highlighted the potential for AI and real-world data (RWD) to strengthen trial design, accelerate recruitment and improve representativeness across diverse patient populations, including those served by community health systems.

In its comments, Premier:

• Recommends prioritizing diversity and access, including participation from community health systems and underserved populations;
• Encourages use of AI and RWD to improve patient recruitment, matching, and trial site selection;
• Identifies key operational priorities, including protocol feasibility assessments and point-of-care eligibility identification;
• Urges FDA to clarify regulatory issues, including anti-kickback implications, synthetic data, digital health technologies and pre-approval information exchange;
• Calls for clear frameworks on informed consent, HIPAA waivers and use of real-world data in clinical trials;
• Recommends strengthening data infrastructure, sharing capabilities and standards to mitigate bias and support interoperability;
• Emphasizes the need for transparency, evaluation metrics and defined use cases to ensure AI trustworthiness; and
• Highlights the importance of regulatory clarity to enable innovation while protecting patients and improving trial efficiency.