By Ahmed Aboulenein
WASHINGTON, April 28 (Reuters) – The U.S. Food and Drug Administration launched a pilot program on Monday aimed at allowing the agency to monitor clinical trial data in real time, a step the agency said could cut years from drug approval timelines and keep the U.S. competitive with China.
The initiative aims to eliminate what FDA Commissioner Marty Makary in a call with reporters called “dead time” in drug development. He said administrative tasks and paperwork take up 45% of the time involved in getting a drug from early testing to submission for an approval decision.
Johnson & Johnson and other drugmakers have said they have started using artificial intelligence to streamline preparation of documents for regulators, cutting that process from hundreds of hours to about 15 minutes.
The initiative gives the FDA access to Phase 1 trial data for assessing safety and efficacy signals without it first going to the company for its own analysis and painstaking preparation.
The FDA said it had received and validated safety data from a midstage trial run by AstraZeneca through health technology firm Paradigm Health testing a drug for mantle cell lymphoma in patients who had not received any prior treatment.
FDA Chief AI Officer Jeremy Walsh said the initiative differs from existing data-sharing frameworks because the FDA is not seeking access to raw patient records.
Instead, the agency would receive only aggregated signals, such as rates of adverse side effects or tumor response percentages, allowing regulators to make decisions without handling underlying clinical data.
Individual patient records would remain with the trial sponsor, avoiding patient privacy concerns, Walsh said.
A second pilot is underway with Amgen, which is conducting an early-stage trial in patients with a form of lung cancer that has not yet spread beyond the chest, known as limited-stage small cell lung carcinoma. Site selection for that study is still ongoing.
The FDA published a request for information seeking industry and public input on the design for broadening the pilot program this summer. The agency said it would accept comments until May 29, with final selection criteria expected in July and pilot selections to be completed in August.
Makary linked the initiative to what he described as growing international competition. He said China surpassed the United States in the number of Phase 1 trials being conducted around 2021 and described the growth since as exponential.
(Reporting by Ahmed Aboulenein; Additional reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot)
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