Comment from Folia Health, Inc.
AnonymousSupportBusiness
Summary: Folia Health, a health informatics organization, supports the FDA's AI-enabled clinical trial pilot program but argues that it must prioritize the integration of real-time, patient-generated experience data. They advocate for specific evaluation metrics, governance requirements, and the inclusion of patient-reported outcomes to ensure the AI models provide a complete picture of drug impact and patient experience.
Folia Health is pleased to submit the attached response to the FDA's Request for Information on Docket No. FDA-2026-N-4390, AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program.
We believe the success of this pilot program relies on the richness of the underlying data, which must represent the full impact of a drug candidate on the health status and disease burden of the patient. This is best accomplished by including real-time patient experience data in these programs, grounded in the methodology established by the FDA's PFDD guidance. Our decade of work with biopharma sponsors generating real-time patient-generated evidence reinforces this position.