On Sept. 30, 2026, the U.S. Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), launched a major effort to transform how clinical trials are designed and conducted — using advanced computational models, real-time analysis, shared infrastructure, and automation to evaluate drugs and biologics faster, at lower cost, and with fewer participants. The new Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, together with three complementary projects announced today, aims to remove barriers that slow clinical development and help promising treatments reach patients sooner.

Today, the clinical development of drugs and biologics often takes more than a decade, costs up to $2 billion on average, and fails more than 90 percent of the time. As a result, promising treatments never reach patients, whether because they are too costly and take too long to get regulatory clearance or because they will not generate enough revenue once approved. Meanwhile, the United States risks losing clinical trial leadership and the economic activity that comes with it.

SURPASS seeks to address those challenges by building continuous, adaptive platform trials that combine predictive computational models, shared trial infrastructure, common control groups, and real-time analysis to enable earlier, smarter decision making that will help speed effective drugs to patients.

By enabling more efficient designs, the program will allow more patients to participate in trials that are more likely to benefit them.

To support this broader transformation of the U.S. clinical trial ecosystem, ARPA-H is also announcing three complementary projects that address critical infrastructure challenges beyond trial design itself:

• STACK will help create more domestic clinical sites and support more efficient trial enrollment. The project aims to use artificial intelligence to accelerate clinical site activation and convert research-naïve sites into clinical trial sites capable of running studies, expanding trial capacity and helping more patients access research opportunities closer to where they live.
• COMMONS will build the connective tissue for nationwide data infrastructure. The project aims to create a privacy-by-design architecture for consent at national scale and enable access to regulatory-grade data. That data access will be critical for rapid clinical trial enrollment, predictive computational models, and other modernization efforts needed across the U.S. clinical trial ecosystem.
• CINCH will focus on patient empowerment and care navigation. The project aims to help patients contribute their own real-world data and benefit directly from it — supporting continuity of care, better care coordination, and faster identification of clinical trials that may be appropriate for them.

Together, these efforts will address multiple barriers that slow clinical development today: outdated trial designs, limited site capacity, fragmented data infrastructure, and a patient experience that is often difficult to navigate. By advancing these efforts in parallel, ARPA-H aims to help build a clinical trial ecosystem that is faster, more connected, more adaptive, and more patient-centered.