Comment from ACRO (Association of Clinical Research Organizations)
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Summary: The Association of Clinical Research Organizations (ACRO) supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials. They advocate for the inclusion of CROs as direct participants, the use of "EDC system" instead of "EHR" to ensure data privacy, and a risk-based, iterative approach to evaluating AI's impact on trial efficiency and safety.
June 24, 2026
Dr. Mallika Mundkur, Deputy Chief Medical Officer
Office of the Commissioner, Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
RE:AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information
Docket (FDA-2026-N-4390)
Dear Dr. Mundkur,
The Association of Clinical Research Organizations (ACRO) is pleased to submit our responses to this RFI.
ACRO's comments are enclosed in the attached PDF document. Please see attachment.
Respectfully submitted,
Karen Noonan, Senior Vice President, Global Regulatory Policy
ATTACHMENT: ACRO RFI Response (PDF)