- ARPA-H has introduced the STACK, COMMONS and CINCH projects
- SURPASS targets trial design, analysis and operations
- The 2026 Healthcare Summit on Dec. 3 will explore AI, access to care and more
The Department of Health and Human Services has launched the Simulation-augmented, Real-time Platform Adaptive Seamless Trials, or SURPASS, program through the Advanced Research Projects Agency for Health to reduce the time, cost and number of participants needed to evaluate drugs and biologics in clinical trials.
As federal health agencies pursue new approaches to medical research and care, HHS’ clinical trial efforts are among the initiatives shaping the sector. Federal health leaders will examine related priorities at the Potomac Officers Club’s 2026 Healthcare Summit on Dec. 3, where representatives from HHS, the Defense Health Agency, the Veterans Health Administration and other organizations will discuss how agencies plan to acquire digital tools and AI, enhance data privacy, expand access to care and advance modernization in fiscal year 2027. Book your spot now to hear directly from senior federal health leaders.
HHS said Wednesday ARPA-H is also introducing three projects that target infrastructure barriers beyond trial design.
What Is SURPASS?
SURPASS is an ARPA-H program that seeks to establish ongoing, adaptive platform trials. In these trials, researchers will use predictive modeling, common control groups, shared infrastructure and real-time data analysis to make decisions earlier in the process. According to HHS, developing drugs and biologics often takes more than 10 years, costs as much as $2 billion on average and fails in more than 90 percent of cases.
The program is organized around three technical areas:
- Phaseless design engine: This area will incorporate digital twins and other predictive models into trial design, simulating clinical and operational results before a trial begins. It will also produce evidence that could help regulators accept these methods.
- Continuous inference engine: This area will support real-time or on-demand analysis that remains valid at any point in a trial. The goal is to allow quick adjustments to trials and to reduce reliance on large conventional control groups without weakening evidence quality.
- Agentic operations layer: This area will automate trial startup and operational tasks and support the addition of new treatment arms. It will also speed up how data is collected, cleaned and assembled into datasets.
Daria Fedyukina, program manager for SURPASS at ARPA-H, said current trials often involve too many steps, duplicated infrastructure and long waits before researchers can tell whether a study is progressing as intended.
“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,” she explained.
What Other Clinical Trial Projects Did ARPA-H Announce?
ARPA-H unveiled three projects addressing clinical trial infrastructure challenges outside of trial design:
- STACK will apply artificial intelligence to speed up clinical site activation and help sites with no previous research experience begin conducting studies. The project seeks to increase domestic trial capacity and allow patients to enroll in trials nearer to home.
- COMMONS will develop a privacy-by-design consent architecture that operates nationwide and provides access to regulatory-grade data. This data will support trial enrollment, predictive modeling and other clinical trial modernization work.
- CINCH will help patients navigate care and share their own real-world data in ways that benefit them. These benefits include improved continuity and coordination of care, as well as quicker matching to suitable clinical trials.
Fedyukina, who also oversees STACK and COMMONS, pointed to operational hurdles such as site activation and fragmented data access as factors that slow trials alongside study design.
“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,” she noted.
Erika Kim, an ARPA-H program manager who oversees CINCH, said clinical trials rely on patients’ real-world data and experiences, not just their participation.
“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,” Kim added.
What Other Research Efforts Has ARPA-H Pursued?
The launch of the SURPASS program follows ARPA-H’s introduction in May of the Intelligent Generator of Research program, which supports the development of AI-powered systems to generate, validate and refine biomedical research for complex and chronic diseases.
In December 2025, the agency selected a Draper-led team for its Computational ADME-Tox and Physiology Analysis for Safer Therapeutics program to develop computational models that predict how patient groups may respond to investigational medicines before clinical trials begin. That selection came weeks after the White House appointed health technology entrepreneur Alicia Jackson as ARPA-H director in October 2025.
ARPA-H previously sought proposals through its Advancing Clinical Trial Readiness initiative, which aims to enable 90 percent of eligible Americans to participate in clinical studies within 30 minutes of their home.
