Comment from FERZ, Inc.
AnonymousSupportBusiness
Summary: FERZ, Inc., a company that builds runtime authorization infrastructure for AI governance, supports the pilot program but argues that the evaluation framework must distinguish between post hoc monitoring and pre-execution authorization. They recommend including specific metrics and criteria to ensure that AI-supported decisions in clinical trials are evaluated against governing constraints before they are acted upon.
FERZ, Inc. respectfully submits the attached response to FDA Docket No. FDA-2026-N-4390, “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program.”
The attached response addresses questions A6b, B2a, B2b, B5a, B5b, and B5c. FERZ’s comments focus on the distinction between post hoc monitoring and pre-execution authorization, and recommend that the pilot include evaluation criteria for independently verifiable authorization artifacts at consequential AI-supported decision points, including dose escalation, cohort expansion, safety-signal response, eligibility determination, and Phase 1 to Phase 2 progression.
FERZ appreciates FDA’s consideration of these comments.