Comment from Exponential Technologies Corp.
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Summary: Exponential Technologies Corp. supports the FDA's proposed pilot program to evaluate AI-enabled technologies in early-phase clinical trials. The company recommends prioritizing oncology and first-in-human studies and suggests specific metrics for measuring trial efficiency, decision quality, and participant safety.
Exponential Technologies Corp. respectfully submits the attached comments in response to Docket No. FDA-2026-N-4390, “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information.”
Our response provides input on pilot program design, evaluation metrics, and success criteria, with particular focus on how structured, framework-aligned AI tools can improve protocol quality, early-phase decision-making, and participant safety while supporting trustworthy AI practices.
We welcome the opportunity to participate in the pilot program or contribute further to the Agency’s efforts in this area.