The U.S. Advanced Research Projects Agency for Health (ARPA-H) launched a new program called “Simulation-augmented, Real-time Platform Adaptive Seamless Trials” (SURPASS), alongside three complementary projects aiming to cut clinical trial timelines. These efforts are part of HHS's broader promotion of AI, real-time data analysis, adaptive trial modifications, data infrastructure, and the global position of the U.S. in the development of drugs and biologics. SURPASS program application summaries are due November 30, 2026.
On September 30, ARPA-H, launched the SURPASS program, soliciting from industry stakeholders “ground-breaking ideas from cross-disciplinary teams in statistics, AI, and clinical trial design, operations, and regulation.” The program aims to build perpetual, adaptive platform trials that combine predictive computational models, shared trial infrastructure, common control groups, and real-time analysis. SURPASS will pursue three technical goals:
- Build a phaseless design engine by integrating digital twins and other predictive models into trial design, simulating clinical and operational outcomes before launch.
- Develop a continuous inference engine 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 by automating key trial startup and operational activities.
Alongside SURPASS, ARPA-H announced three related initiatives:
- “STACK,” which aims to create more domestic clinical sites and support more efficient trial enrollment, using AI to speed clinical site activation.
- “COMMONS,” which will build nationwide data infrastructure to enable access to regulatory-grade data.
- “CINCH,” which seeks to help patients to contribute their real-world data (RWD), which could help them join clinical trials faster. We recently analyzed online here how HHS has been showing increasing willingness to consider RWD in its medical product reviews.
This program announcement comes after HHS laid out plans for “Operation TrialBlazer,” a coordinated initiative to keep early-stage clinical research in the U.S. Each of these efforts has arisen in part in response to China's rise in the pharmaceutical and biotechnology arena, and alongside FDA's voicing heightened concerns about Good Clinical Practice at clinical trial sites outside the U.S.
In addition to SURPASS, HHS is promoting the use of AI in clinical trials through the launch of the CMS Medicare App Library, which we described online here following its launch event. Meanwhile, FDA announced a “real-time clinical trials” pilot program to permit agency reviewers to review study data simultaneously with its collection by investigators. These varied efforts to modernize and speed up the drug development and clinical trial processes can present opportunities to speed up trials, yet it may also be challenging for sponsors to build the infrastructure for and to operationalize these programs.
Next steps
Those interested in the SURPASS program must submit a summary of their proposal by November 30, 2026. HHS is holding an informational webinar on SURPASS on October 15, registration for which is due October 12. ARPA-H also announced a “Proposer's Day Event,” scheduled for November 6, registration for which is due by October 28; at this event, potential SURPASS program applicants will have opportunities to identify team members, and present posters to help members of the proposer community find collaborations.
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