US FDA plans to use AI to accelerate clinical trial reviews

Artificial intelligence (AI) will speed up the assessment of clinical trial data and drug reviews in general, according to the US FDA, which announced its intention to ramp up use of the technology.

The US drug regulator signaled its plan to make greater use of AI last week, explaining the aim is to use the approach to accelerate various tasks, including clinical trial data assessment.

An agency spokesperson told Clinical Insider, “The FDA is committed to enhancing efficiency and consistency in scientific reviews and drug development to better serve the American public.

“FDA Commissioner [Martin] Makary has emphasized AI is a tool to support—not replace—human expertise. When used responsibly, AI can enhance regulatory rigor by helping predict toxicities and adverse events for certain conditions,” the spokesperson added.

The idea is to use AI to make drug reviews and other “routine” tasks more efficient to free up experts to focus on other activities, the spokesperson said.

“The FDA has completed its first AI-assisted scientific review pilot and is now implementing an aggressive, agency-wide AI rollout. By June 30, all FDA centers will be operating on a secure, unified generative AI platform integrated with the agency’s internal data systems. This initiative aims to reduce non-productive tasks, accelerate review timelines, and empower scientists to focus on higher-value activities.”

The spokesperson framed the decision to embrace AI as part of a wider efficiency drive.

The spokesperson said, “As Commissioner Makary stated, ‘The opportunity to reduce tasks that once took days to just minutes is too important to delay.’ This reflects the FDA’s dedication to modernizing its processes and ensuring timely access to safe and effective therapies for the American people.”

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