Comment from Truveta

Truveta appreciates the opportunity to provide comments on FDA's Expedited IND Pilot Program under Operation TrialBlazer. We support FDA's efforts to accelerate the transition from drug discovery to first-in-human studies by improving the quality and efficiency of early clinical development. Truveta brings together daily updated electronic health record (EHR) data for more than 130 million patients across 30 leading U.S. health systems. Truveta's longitudinal real-world data include structured and unstructured clinical information, linked claims, mortality, and social determinants of health data to support clinical research and evidence generation. Truveta also provides AI-enabled data normalization and analytics that help researchers evaluate patient populations, protocol feasibility, and study design. As FDA seeks to streamline IND preparation and accelerate U.S.-based clinical research, Truveta believes high-quality longitudinal real-world data can strengthen planning activities that occur before first-in-human studies begin. Specifically, Truveta can support sponsors and participating research institutions through: Disease characterization and natural history by using longitudinal real-world data to better understand disease progression, standards of care, and target patient populations during early development. Protocol design and feasibility optimization by enabling iterative evaluation of inclusion and exclusion criteria, assessment of cohort size, optimization of study endpoints, and identification of infeasible protocol elements before trial initiation, helping reduce protocol amendments. Representative U.S. patient populations by leveraging data sourced from community health systems that care for patients across diverse geographies and care settings, allowing sponsors to evaluate whether proposed study populations reflect real-world clinical practice. Site and principal investigator selection by identifying care sites and providers with experience caring for patients who meet study criteria, improving study feasibility and reducing the risk of low-enrolling sites. Patient recruitment planning through identification of eligible patient populations and facilitation of collaboration with Truveta member health systems where there is mutual interest. Truveta does not enroll patients directly but can facilitate introductions and collaboration opportunities between sponsors and participating health systems. Health system collaboration by facilitating efficient connections between sponsors and participating health systems for activities including site selection, patient recruitment, augmented data capture, pragmatic studies, and long-term follow-up, where appropriate and mutually agreed upon. Truveta is uniquely positioned to support these activities through its daily updated longitudinal clinical data, AI-enabled data normalization, advanced analytics capabilities, and direct relationships with leading U.S. health systems. Additional implementation details, technical materials, and non-public examples have been provided separately through FDA's confidential submission process. Truveta welcomes the opportunity to brief FDA leadership and relevant technical staff regarding these capabilities through an appropriate non-public discussion.