Federal health agencies in the United States have unveiled a comprehensive plan to speed up Phase 1 clinical trials by an estimated 6 to 12 months.
The initiative, called Operation TrialBlazer, is led by the Department of Health and Human Services (HHS) and involves the FDA, NIH, and other agencies.
Key FDA measures include a streamlined investigational new drug (IND) pilot program, updated guidance on advanced computer models for dose selection, and clearer Chemistry, Manufacturing, and Controls (CMC) requirements to reduce delays in first‑in‑human trials.
The NIH will use its clinical trial networks and real‑world data to test novel study designs and expand access to trials in underserved and rural communities.
The reforms are designed to make U.S. clinical research more attractive and competitive globally, especially against countries like China and Australia that are seen as having faster trial timelines.
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HHS unveils plan to speed up ph. 1 trials by 6 to 12 months
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