HHS Launches SURPASS and New Efforts to Accelerate Faster, Smarter Clinical Trials

New ARPA-H efforts aim to cut clinical trial timelines, reduce patient burden, and strengthen U.S. leadership in clinical development

AUSTIN, TX-SEPTEMBER 30, 2026-The U.S. Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), today 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.

"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."

Together, these efforts advance the Trump administration's work to modernize clinical development, reduce unnecessary delays and costs, and strengthen U.S. competitiveness in biotechnology and drug development. By making clinical trials faster, more efficient, and less burdensome for patients, ARPA-H aims to help promising treatments reach patients sooner while reinforcing the United States as a global leader in medical innovation.

"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 can learn in real time, adapt when needed, and generate stronger evidence faster with less operational burden."

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.

The program will pursue three coordinated technical areas:

• Build a phaseless design engine for faster trials with fewer patients by integrating digital twins and other predictive models into trial design, simulating clinical and operational outcomes before launch, and developing the evidence needed to support regulatory confidence in these approaches.
• Develop a continuous inference engine for faster decisions by enabling always-valid, real-time or on-demand analysis, supporting rapid trial adaptations, and reducing the need for large conventional control groups while maintaining rigorous evidence generation.
• Create an agentic operations layer to reduce time and cost by automating key trial startup and operational activities, supporting onboarding of new treatment arms, and speeding data collection, cleaning, and dataset construction.

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.

"Clinical trials are often slowed not just by study design, but by operational barriers like site activation, fragmented data access, and a patient experience that can often be very burdensome for patients and their caregivers," said SURPASS Program Manager Daria Fedyukina, overseeing STACK and COMMONS as well. "STACK and COMMONS are designed to tackle those barriers directly so that more patients can connect to trials and more trials can run efficiently in the United States."

"Patients don't just participate in clinical trials, their real-world data and experiences are needed to power them," said Program Manager Erika Kim, Ph.D., overseeing CINCH. "CINCH is going to make it easier for patients to contribute their data into trials, so research better reflects patient experiences while motivating continuity of care and providing faster connections to appropriate clinical trials."

Beyond individual trials, these efforts are intended to create broadly useful tools, frameworks, and examples for the U.S. clinical trial ecosystem. 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.

Learn more about SURPASS on the ARPA-H program page, including information about the Innovative Solutions Opening. Learn more about COMMONS, CINCH, and STACK on the Award Directory.