US HHS floods the zone with clinical trial reform, from Operation TrialBlazer to ARPA-H
anshulkundaje · x · 2026-10-16
Saloni Dattani rounds up a wave of US clinical trial reforms announced since June. Operation TrialBlazer (HHS/FDA) aims to bring early-stage clinical research back to the US amid China's biotech surge, with FDA draft guidance on single pivotal trials plus confirmatory evidence, master protocols (platform/basket trials), relaxed phase-one manufacturing requirements, model-based dose selection replacing animal toxicity studies, an IND-prep pilot, and rolling submissions. NCI is streamlining trial activation and enrolment, ONC is exploring EHR-based patient-trial matching, and ARPA-H announced four trial-acceleration programs its director called possibly its largest single-area investment suite.
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