HHS Launches SURPASS Program to Accelerate Clinical Trials

The U.S. Department of Health and Human Services has launched a multi-component effort to improve the speed and efficiency of clinical trials. The centerpiece is the SURPASS program, which integrates digital twins, predictive models, and adaptive trial designs to speed up drug development. This initiative is designed to eliminate duplication, ensure more efficient enrollment, and provide patients with earlier access to promising therapies.

HHS Secretary Robert F. Kennedy Jr. Spoke at a launch event held at UT Dell Medical Center in Texas. The Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program aims to build continuous adaptive-platform trials. It will incorporate predictive computational models, shared trial infrastructure, common control groups, and real-time analysis. SURPASS focuses on three key areas: a phaseless design engine, a continuous inference engine, and an agentic operations layer.

The continuous inference engine enables real-time analysis to support rapid trial adaptation and minimizes the need for large conventional control groups. The agentic operations layer automates trial startup and operational activities to reduce costs and time. This includes onboarding for new treatment arms and accelerated data collection and cleaning. SURPASS program manager Daria Fedyukina stated that the program aims to evaluate drugs and biologics faster, at lower cost, and with fewer participants, allowing more patients to join trials that are more likely to benefit them.

Complementary initiatives target site activation, data sharing, and patient engagement

Alongside SURPASS, the Advanced Research Projects Agency for Health (ARPA-H) announced three complementary projects: STACK, COMMONS, and CINCH. ARPA-H will seek ideas from leaders in clinical trial design, operations, regulation, AI, and statistics to help achieve program goals.

STACK uses artificial intelligence to accelerate clinical trial site activation and convert research-naïve sites into functional ones. COMMONS creates a national consent architecture to improve infrastructure for connecting and sharing health data nationwide using a privacy-by-design framework. CINCH focuses on patient empowerment, helping patients contribute their own real-world data across institutions to support care continuity and identify appropriate trials.

Goals include cutting trial timelines from a decade to four years or less

Clinical development for drugs and biologics in the U.S. can take a decade and cost up to $2 billion. Approximately 90% of drugs that start the clinical trial process ultimately fail. Together, these new efforts could shorten the clinical trial timeline from a decade to four years or less, according to SURPASS program manager Daria Fedyukina.

The U.S. Government launched four ARPA-H initiatives to modernize clinical trial design, site activation, consent, and patient data collection.

Broader context: U.S. Seeks to regain clinical trial leadership amid global competition

Officials warn the U.S. has fallen behind China in trial volume and R&D funding, framing the initiative as essential to maintaining biomedical competitiveness. Six years ago, China surpassed the U.S. In the number of clinical trials. The U.S. has also fallen behind China in R&D funding and translational science since then.

Acting FDA Commissioner Kyle Diamantas spoke during the event about drug developers moving early-stage trials overseas due to regulatory and administrative friction. He stated that modernizing regulatory science is not about cutting corners on safety but about using gold-standard science and tools to work smarter and cut delays without reducing protection.

Caitlin Frazer, executive director of the National Security Commission on Emerging Biotechnology, stated that China’s approach has been to steal, scale, and strangle American competitors in biotech. The SURPASS program and complementary initiatives are intended to establish a clinical trials ecosystem that is fast, adaptive and proudly anchored to the United States. HHS Secretary Robert F. Kennedy Jr. Stated that America should lead the world in turning medical breakthroughs into treatments for patients.

The new ARPA-H rollout follows the HHS-wide Operation TrialBlazer Initiative, which included an FDA pilot program to reduce time and burden for first-in-human studies. That initiative opened for applications last month and will remain open until October 30. The FDA downsized by more than 3,000 staffers last year due to layoffs or incentivized early retirements. This year, the agency aims to hire approximately 2,200 staffers, including some recently departed employees. In the summer of last year, the FDA rolled out an AI tool named Elsa designed to boost efficiency, though experts have called for more details about how it works and what benchmarks it uses.

An informational webinar will be held on October 15 to allow stakeholders to offer ideas for the program goals.