Comment from Truveta

Truveta’s public comment provides a high-level overview of capabilities and considerations relevant to FDA’s RFI on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). Truveta brings together daily refreshed EHR data for more than 130 million patients, sourced directly from leading U.S. health systems united by a shared mission of Saving Lives with Data. This trusted partnership supports data quality, traceability to the clinical source, and access to longitudinal clinical data for research and evidence generation. In the attached deck, Truveta outlines how its AI capabilities can be used to improve and accelerate early-stage clinical trials through: -PI and site selection -Patient recruitment -Data collection and monitoring Truveta is uniquely positioned to support these activities through its direct connection to 30 member health systems, daily refreshed data that enable near real-time identification and characterization of study populations, AI-driven tokenization and normalization capabilities, and Truveta Intelligence tools. Additional implementation details, technical materials, and non-public examples have been provided separately through FDA’s confidential submission process. Truveta would welcome the opportunity to brief FDA leadership and relevant technical staff on these materials through an appropriate non-public discussion.