FDA Embraces AI to Crack Down on Dishonesty in Clinical Studies

The FDA is getting better at detecting misapplied practices in clinical trial studies with the help of artificial intelligence, agency Commissioner Robert Califf said Wednesday.

“You apply AI to an application, you find out when people are cheating,” he said. “And if you’ve cheated in the past, watch out because it’s going to be easy to apply AI to the applications we already have to catch in the future.”

“This is an arms race, in a way, because we’re now seeing applications that are generated with AI,” Califf said. “And so we got to stay a step ahead so that we can keep up and also keep a handle on that.”

The Food and Drug Administration leader’s remarks were made at a fireside chat at GRx+Biosims 2024, a generic and biosimilar industry conference where he discussed agency inspections, the biosimilar and generic industry, and AI use in the health-care industry.

Califf said he was particularly concerned about clinical studies, which need to be executed with a “higher degree of integrity.”

AI is likely to play a crucial role in medical supply chain management and continue to transform product development, Califf and other high-ranking officials for the FDA wrote in an Oct. 15 JAMA Network Special Communication. Strong agency oversight is needed to protect the long-term success of industries, they said.

The analysis reviewed the history of the FDA’s AI regulation and outlined its potential uses in medical product development, clinical research, and clinical care. The agency also presented concepts that merit consideration as the regulatory system adapts to AI’s challenges.

“I don’t like being a cop,” Califf said Wednesday. “But I also don’t like people who cheat the system. So if you’re cheating out there, we’re going to be applying AI to your stuff.”

“We’re going to get much better at detecting dishonest activity.”