HHS Launched AI Clinical Trial Program
The five-year SURPASS initiative aims to replace traditional, siloed clinical trial phases with real-time, AI-driven adaptive modeling.
Updated on Sept. 30, 2026 in Artificial Intelligence

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The Department of Health and Human Services (HHS) has announced the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program. This research-stage initiative will utilize artificial intelligence and computational models to accelerate the timeline of clinical testing.
Why it matters
The program seeks to address the inefficiencies of current drug development by moving away from strictly delineated trial phases. It intends to streamline the clinical research process by integrating cross-disciplinary teams in statistics, AI, and trial design.
The program is structured to operate over a 5-year timeline. It will replace fixed, multi-stage trial designs with adaptive, real-time computational models, though the specific algorithmic benchmarks for success remain to be established.
The players
Department of Health and Human Services
The U.S. federal executive department responsible for protecting the health of all Americans and providing essential human services.
Advanced Research Projects Agency for Health
An agency within the HHS that supports high-risk, high-reward research to drive biomedical and health breakthroughs.
The details
Managed by the Advanced Research Projects Agency for Health (ARPA-H), SURPASS encourages collaboration between experts in statistics, clinical trial design, and artificial intelligence. The approach relies on computational modeling—the use of mathematical simulations to predict outcomes—to create a seamless testing environment. By moving away from traditional, sequential trial phases, the program aims to enable continuous adjustments to clinical protocols based on real-time data.
Timeline
Fall 2026: The SURPASS program is scheduled to begin.
The Tech Race
SURPASS represents a structural pivot for ARPA-H, moving the agency toward integrating predictive AI modeling directly into the pipeline of medical validation. It follows an industry-wide trend of replacing legacy trial architectures with dynamic, data-heavy frameworks.
Patients and healthcare providers will not see immediate changes as the program is currently in the research-design phase. Impact will emerge as the program develops new software tools and trial methodologies intended to bring experimental treatments to market faster.
The takeaway
The success of SURPASS depends on whether computational modeling can accurately replicate the rigor of human-led trial phases. Watch for the program launch in fall 2026 to see if participating research teams release the first datasets generated by these adaptive models.
Further reading
For broader context on how machine learning is reshaping drug development, see the latest research in Artificial Intelligence.
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