FDA to pilot real-time clinical drug trials through cloud and AI

FDA Commissioner Marty Makary (right) speaking Tuesday at the agency's headquarters in Silver Spring, Md., alongside chief artificial intelligence officer Jeremy Walsh. Frank Konkel/Government Executive

Through a new pilot program announced this week, the Food and Drug Administration will use artificial intelligence and cloud computing to monitor clinical trial data in real time, an effort that could ultimately shave years off the approval timelines for new drugs, devices and medications.

FDA commissioner Marty Makary announced “the first ever real-time clinical trial” Tuesday at a press conference held at FDA’s headquarters in Silver Spring, Md. “Today is a milestone day for us to challenge the assumption that it takes 10 to 12 years for a new drug to come to market.”

Makary said about 45% of the time between when a company conducts a Phase 1 clinical trial and submits its applications—which can sometimes be millions of ...