SURPASS Clinical Trials Program Aims to Speed Drug Development

The U.S. Department of Health and Human Services (HHS) launched the ARPA-H SURPASS clinical trials program on 30 September 2026. Three companion projects launched alongside it to address operational and statistical bottlenecks that keep promising treatments out of reach.

Clinical development of drugs and biologics typically runs more than a decade, costs up to $2 billion on average, and fails more than 90 percent of the time, according to the Advanced Research Projects Agency for Health (ARPA-H). Treatments are lost either because they cost too much and take too long to win regulatory clearance, or because they will not generate enough revenue once approved. ARPA-H also frames the problem as a competitive one: the United States risks losing clinical trial leadership, and the economic activity that comes with it.

What the SURPASS clinical trials program will build

SURPASS stands for Simulation-augmented, Real-time Platform Adaptive Seamless Trials. The program funds continuous, adaptive platform trials that combine predictive computational models, shared trial infrastructure, common control groups, and real-time analysis. The goal is earlier and better-informed decisions about which treatments work, so that more patients enroll in trials likely to help them.

“America should lead the world in turning medical breakthroughs into treatments for patients,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down. Through ARPA-H, we are building a modern clinical trial system that can generate rigorous evidence faster, reduce the burden on patients, and move effective treatments from discovery to the people who need them sooner.”

ARPA-H places the effort inside the administration’s broader push to modernize clinical development, cut unnecessary delays and costs, and strengthen U.S. competitiveness in biotechnology and drug development.

“Today’s clinical trial system often requires too many stops, too much duplicated infrastructure, and too much time before researchers can understand whether a trial is on the right track,” said SURPASS Program Manager Daria Fedyukina, Ph.D. “SURPASS is developing the technology and biostatistical frameworks needed to analyze trial data as it accumulates, allowing teams to learn in real time, adapt when needed, and generate stronger evidence faster with less operational burden.”

Three technical areas for faster trials

A phaseless design engine, which integrates digital twins and other predictive models into trial design, simulates clinical and operational outcomes before launch, and develops the evidence needed to give regulators confidence in those methods.
A continuous inference engine, which enables always-valid, real-time or on-demand analysis, supports rapid trial adaptations, and reduces the need for large conventional control groups while keeping evidence generation rigorous.
An agentic operations layer, which automates key trial startup and operational activities, supports onboarding of new treatment arms, and speeds data collection, cleaning, and dataset construction.

Cost, standards and regulatory confidence

The design ideas on offer, shared control groups, simulated trial arms, and automated operations, move cost rather than erase it. Each one trades conventional trial spending for statistical groundwork and infrastructure that only pays off once many sponsors use it. That is the recurring lesson of the economics of trial design: smaller control arms require stronger prior information, and adaptive designs require systems that no single study can justify on its own.

ARPA-H says the effort should produce broadly useful tools, frameworks, and examples. Publicly available regulatory documents, validated standards, and real-world demonstrations of modernized trial methods could help sponsors, sites, regulators, and technology developers adopt more adaptive and efficient approaches across many diseases. The published standards are the part worth watching for teams already testing AI-assisted trial screening, and for anyone tracking ethical AI integration in drug development.

What comes next

ARPA-H has not published award values or a timeline for the three companion projects in this announcement. Further detail on SURPASS, including the Innovative Solutions Opening, is available on the ARPA-H program page, and COMMONS, CINCH, and STACK are listed in the agency’s Award Directory.

Source: HHS launches SURPASS and new efforts to accelerate faster, smarter clinical trials, ARPA-H, 30 September 2026.