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FDA Requests Input on Trustworthy AI Clinical Trial Pilot

5/12/2026

28 5 Full Breakdown

Summary

Story summary

The FDA issued an RFI for an AI-enabled pilot in early-phase clinical trials.
The pilot follows a “trustworthy AI” approach using the NIST AI Risk Management Framework.
It will create standards, metrics, and governance for AI in recruitment, dosing, endpoints, and safety monitoring.
Sponsors must comment by May 29 2026, define AI context, and address reliability, privacy, fairness, and confidentiality.

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Story summary

The FDA issued an RFI for an AI-enabled pilot in early-phase clinical trials.
The pilot follows a “trustworthy AI” approach using the NIST AI Risk Management Framework.
It will create standards, metrics, and governance for AI in recruitment, dosing, endpoints, and safety monitoring.
Sponsors must comment by May 29 2026, define AI context, and address reliability, privacy, fairness, and confidentiality.