U.S. launches ARPA-H programs to modernize clinical trials

The Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection amid concerns about U.S. competitiveness with China. The main program, Simulation-augmented, Real-time Platform Adaptive Seamless Trials, or SURPASS, will use computational models, real-time analysis and automation to evaluate drugs and biologics faster, at lower cost and with fewer participants.

SURPASS will focus on a phaseless design engine that uses digital twins and predictive models to simulate outcomes before trials launch, a continuous inference engine intended to reduce reliance on large conventional control groups, and an agentic operations layer to automate startup tasks, onboarding for new treatment arms and data collection and cleaning. ARPA-H said the approach is meant to let teams analyze data as it accumulates and adapt studies in real time.

ARPA-H also announced STACK, COMMONS and CINCH. STACK will use AI to accelerate clinical site activation and help research-naïve sites run studies, COMMONS will build a national consent architecture for data access across the U.S. clinical trial ecosystem, and CINCH will help patients contribute real-world data. HHS framed the projects as part of a broader push to reduce delays, duplicated infrastructure and unnecessary costs in clinical development.