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FDA Launches Real-Time Trial Pilot to Slash Idle Time

4/29/2026

Summary

FDA Launches Pilot

The U.S. Food and Drug Administration launched a pilot for real-time clinical trials to cut idle time.
AstraZeneca’s Phase 2 mantle-cell lymphoma trial and Amgen’s early-stage lung cancer study will test the system while FDA officials say safety remains the top priority.
Commissioner Marty Makary said traditional trials take 10-12 years with 45% of Phase 1-to-submission time idle, prompting the FDA to expand the pilot this summer.

Summary

FDA Opens Comment

The FDA opened a 30-day public comment period on the real-time clinical-trial pilot, accepting submissions via regulations.gov.
Paradigm Health will supply the real-time data platform that collects and transmits participant reports for the AstraZeneca and Amgen studies.
The AstraZeneca Phase 2 lymphoma trial will run at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania.
Amgen’s Phase 1b small-cell lung carcinoma trial is also part of the pilot.

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FDA Launches Pilot

The U.S. Food and Drug Administration launched a pilot for real-time clinical trials to cut idle time.
AstraZeneca’s Phase 2 mantle-cell lymphoma trial and Amgen’s early-stage lung cancer study will test the system while FDA officials say safety remains the top priority.
Commissioner Marty Makary said traditional trials take 10-12 years with 45% of Phase 1-to-submission time idle, prompting the FDA to expand the pilot this summer.

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