The U.S. Food and Drug Administration seeks to accelerate clinical trials of new medicines by using AI to streamline the laborious process of collecting and submitting study data, The Wall Street Journal’s Brian Gormley reports. Medical centers typically pull clinical trial data from electronic health records and manually enter it into a data capture system before drugmakers review and submit it to the FDA. This summer, the agency plans to pilot a system in which AI extracts the data and submits it in real time to both the regulator and the pharmaceutical company, the author notes. As a prelude to the pilot, drugmakers AstraZeneca (AZN) and Amgen (AMGN) agreed to test real-time data reporting in clinical trials of specific cancer medicines. Startup Paradigm Health is providing AI capabilities for this proof-of-concept work, the report adds.
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