US FDA Piloting Use of AI for 'Real-Time' Clinical Trials

Goal Is for Faster, Better Treatment Innovation, Drug Therapies Marianne Kolbasuk McGee (HealthInfoSec) • April 29, 2026

The U.S. Food and Drug Administration will test out real-time clinical trials using artificial intelligence tools and data science. The goal is to accelerate the development of promising new drug therapies, which the agency said are slowed by data and procedural bottlenecks.

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The agency said Wednesday a real-time clinical trial has already involved "successful initiation" of two proof-of-concepts - one by pharmaceutical giant AstraZeneca and the other by Amgen.

AstraZeneca is conducting a phase 2 multi-site trial called Traverse involving patients with mantle cell lymphoma who haven't yet received treatment. That trial involves participation from the University of Texas MD Anderson Cancer Center and University of Pennsylvania.

Amgen is conducting a Phase 1b trial called Stream-SCLC with patients ...