HHS Launches AI Initiatives to Accelerate Clinical Trials

The initiatives aim to streamline trial design, expand patient enrollment, improve access to research data, and help identify suitable clinical trials for cancer patients.

The US Department of Health and Human Services (HHS) has announced four initiatives to accelerate clinical trials using artificial intelligence (AI), real-time data analysis, and advanced computational models. The initiatives aim to streamline trial design, expand patient enrollment, improve access to research data, and help identify suitable clinical trials for cancer patients.

The department’s Advanced Research Projects Agency for Health (ARPA-H) will lead the efforts, which include the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program and three complementary projects: STACK, COMMONS and CINCH.

SURPASS will develop AI-powered platforms that allow researchers to simulate clinical trials, analyze incoming data and adapt trial procedures as evidence accumulates. The program focuses on three technical areas: simulation-based trial design, continuous data analysis and an agentic AI operations layer to automate trial startup, accelerate data collection and support trial operations.

According to HHS, the approach is intended to enable faster decision-making and potentially reduce the number of participants required for certain trials while maintaining regulatory compliance. ARPA-H has scheduled informational sessions for interested organizations, with solution summaries due November 30.

“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,” said Daria Fedyukina, SURPASS program manager.

Three Projects Target Enrollment, Data Access and Cancer Trials

STACK will use AI to accelerate clinical site activation and help research-naïve healthcare facilities become clinical trial sites. Evidence Health is the project's prime awardee and could receive up to $41.18 million, according to ARPA-H.

COMMONS will develop national data infrastructure to support large-scale consent and access to regulatory-grade research data. The initiative targets more than 40 million individuals and three million linked records. Evidence Health could receive up to $49.9 million for the project.

The University of Texas at Austin's Dell Medical School is partnering with Evidence Health on both initiatives, contributing to clinical research site preparation and the development of a national research data resource.

CINCH focuses on cancer research by enabling adults to contribute their health data and better understand clinical trials that may be appropriate for them. Courage Health is the prime awardee and could receive up to $8.95 million.

Builds on Broader US Clinical Trial Reforms

The initiatives follow HHS's launch of Operation TrialBlazer in June, a department-wide effort to support clinical trials through pilot programs, public-private partnerships and stronger patient connections.

The Food and Drug Administration also announced an AI and cloud computing pilot in April to monitor clinical trial data in real time. An FDA official estimated that the effort could reduce overall clinical trial timelines by as much as 40% without compromising patient safety.

HHS estimates that developing drugs and biologics often takes more than a decade, costs up to $2 billion on average, and fails more than 90% of the time, highlighting the challenges the new initiatives aim to address.

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