HHS Announces Department-Wide Clinical Trial Initiative

Agency-wide effort targets US clinical trial timelines, enrollment, and regulatory barriers.

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The HHS announced a department-wide initiative to enhance clinical research and accelerate new treatment development.
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Operation TrialBlazer outlines strategies to address global competition in clinical trials, particularly from China.
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The FDA is proposing a pilot program to shorten timelines from drug identification to Phase 1 trials by clarifying regulatory expectations.
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The roadmap includes plans for a single IRB model for multisite studies to streamline trial startup and enrollment.
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NIH is increasing support for clinical trials and promoting the use of AI and real-world data to enhance therapy development.

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