Comment from Autonomic Resilience Collective (ARC)
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Summary: The Autonomic Resilience Collective, an independent nonprofit research organization, supports the pilot program but argues that AI-enabled safety monitoring must be anchored to within-subject baselines rather than population norms. They recommend that the FDA include within-subject statistical foundations in the pilot's scope to improve the interpretability and reliability of safety signals in small early-phase cohorts.
The Autonomic Resilience Collective (ARC) submits this public comment in response to the FDA’s Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Our full comment is attached as a PDF document.
ARC is an independent nonprofit research organization that develops within-subject methods for longitudinal biometric data. Our comment addresses a single foundational issue cutting across the pilot’s safety-monitoring and trustworthiness objectives: AI-enabled safety monitoring in early-phase trials will produce unreliable signals unless it is anchored to a within-subject baseline. Population-norm anomaly detection misfires systematically in small, selected early-phase cohorts — in both directions.
We present peer-reviewed longitudinal evidence and three specific recommendations for the pilot program guidance. See attached.