ACRO Urges FDA to Include CROs in AI Clinical Trial Pilot

• ACRO is urging the U.S. FDA to allow contract research organizations (CROs) to participate directly in its proposed AI-enabled early-phase clinical trial pilot.

• The industry association argues that CROs’ experience across global clinical studies can help improve AI governance, trial efficiency, and regulatory decision-making.

The Association of Clinical Research Organizations (ACRO) has called on the U.S. Food and Drug Administration (FDA) to explicitly include contract research organizations (CROs) as direct participants in its proposed AI-enabled optimization pilot for early-phase clinical trials. The request was submitted in response to the FDA’s Request for Information (RFI) on using artificial intelligence to improve the efficiency, speed, and quality of clinical trial decision-making. 

According to ACRO, CROs should participate directly in the pilot rather than through sponsor relationships because they oversee a substantial proportion of global clinical research. The association noted that its member companies conducted or participated in 7,634 clinical studies involving approximately 1.4 million patients and volunteers during 2025, giving them broad operational insight across therapeutic areas and geographies. 

Beyond direct participation, ACRO recommended that the FDA establish recurring multi-stakeholder workshops to facilitate ongoing dialogue between regulators and industry as the pilot evolves. The organization said regular engagement would help identify operational challenges, refine AI governance approaches, and support implementation of real-time clinical trial technologies. 

The FDA introduced the proposed AI pilot as part of its broader real-time clinical trial initiative, which explores how AI-enabled technologies and continuous data sharing could accelerate early-phase drug development while maintaining regulatory oversight. The agency has since extended the public comment period following requests from stakeholders for additional time to provide feedback. 

“Regulators around the globe are grappling with the complex challenges of designing regulatory regimes for AI oversight that foster patient safety, data integrity, and high evidentiary standards – without stifling innovation.” 

Karen Noonan, Senior Vice President of Regulatory Policy at ACRO