What is the FDA's new pilot program involving artificial intelligence in clinical trials, and which companies and diseases are involved?

The FDA has launched a pilot program to use artificial intelligence in clinical trials, as announced in its press release. Pharmaceutical companies AstraZeneca and Amgen are collaborating with the FDA on 'real-time clinical trials,' where data are transmitted to the FDA during the trial rather than only after its completion. These trials are specifically focused on testing drugs for lymphoma and lung cancer.

How does the FDA's 'real-time clinical trial' approach differ from traditional clinical trial data submission?

Unlike traditional clinical trials—where data are submitted to the FDA only after the trial concludes—the FDA's 'real-time clinical trial' approach involves sending data to the agency as the trial is actively underway. This shift enables ongoing monitoring and potentially faster regulatory assessment, and it is currently being piloted with AstraZeneca and Amgen in trials for lymphoma and lung cancer.

FDA Looks to Expand Real-Time Drug Clinical Trials

May 1, 2026

The FDA seeks input to expand an AI-driven pilot program enabling real-time data submission for clinical trials, currently testing drugs for lymphoma and lung cancer with partners like AstraZeneca and Amgen.

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2026-05-01

FDA Looks to Expand Real-Time Drug Clinical Trials

FDA Looks to Expand Real-Time Drug Clinical Trials

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