The U.S. Department of Health and Human Services unveiled new programs designed to speed and modernize clinical development, citing intensifying global competition and operational bottlenecks that slow trial timelines. The centerpiece is SURPASS, funded and launched through ARPA-H, which aims to shift from traditional, phase-by-phase trials toward “simulation-augmented, real-time platform adaptive seamless trials.” HHS also announced three ARPA-H projects targeting clinical trial enrollment, building nationwide data infrastructure, and empowering patients involved in research. The move reflects data showing China’s growing share of early-stage trials and a push to make the U.S. more attractive for sponsors. It follows FDA efforts to streamline early trial execution, including Operation Trialblazer, and comes after European drugmakers warned they were losing ground to faster-loading trial environments.
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