Comment from Tempus AI
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Summary: Tempus AI, a multimodal data and AI company, supports the FDA's proposed pilot program for AI-enabled optimization of early-phase clinical trials. They provide specific methodological recommendations for trial archetypes, therapeutic areas, and the inclusion of foundation models in the pilot's scope.
Tempus AI appreciates the opportunity to provide input on the FDA’s Request for Information regarding the "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program" (Docket No. FDA-2026-N-4390).