US health agency launches initiatives to modernize clinical trials and accelerate evidence generation

New initiatives from the US Department of Health and Human Services aim to make clinical trials faster, more efficient and less burdensome for participants through adaptive designs, predictive models and automation. Supporting projects will address trial capacity, data access and patient participation, including opportunities for patients to contribute their own real-world data.

The Baseline

• The Advanced Research Projects Agency for Health, the US Department of Health and Human Services, has launched SURPASS to develop trial approaches combining predictive models, shared infrastructure, real-time analysis and automation.
• Three complementary projects address trial site capacity, data access and consent, and patient contributions of real-world data.
• The launch comes as the FDA establishes dedicated AI and RWE analytics divisions within its new Office of Innovation and Clinical Trial Modernization.

The US Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), has launched a program to develop more adaptive and efficient clinical trials. Announced on September 30, 2026, Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) brings together new approaches to trial design, analysis and operations, alongside three complementary infrastructure projects.

The program comes amid international competition to attract clinical research investment, with China’s expanding role in global clinical trials adding to the focus on research capacity and efficiency. HHS positions the initiatives as part of efforts to strengthen US competitiveness in biotechnology and drug development by addressing delays, costs and infrastructure barriers.

For the real-world evidence (RWE) community, two projects are particularly relevant. COMMONS aims to develop infrastructure for consent and access to regulatory-grade data, supporting trial recruitment and predictive modeling. CINCH focuses on helping patients contribute their own real-world data (RWD), with potential benefits for care coordination and identifying suitable clinical trials.

“Patients don't just participate in clinical trials, their RWD and experiences are needed to power them,” said Erika Kim (ARPA-H), program manager overseeing CINCH.

These projects address a practical issue for evidence generation: making patient data accessible and usable across research and care. The third complementary project, STACK, focuses on expanding trial site capacity, including using AI to accelerate site activation.

SURPASS itself targets the design and conduct of trials. The program seeks to develop ongoing adaptive platforms in which treatments can be evaluated using shared infrastructure and common control groups, with analyses informing decisions as data accumulate. Its ambition is to reduce development time, cost and participant burden while maintaining reliable evidence generation.

The program will pursue three coordinated technical areas:

1. Trial design: A “phaseless design engine” will integrate digital twins and other predictive models to simulate clinical and operational outcomes before trials begin. The aim is to develop faster trials requiring fewer participants, alongside evidence to support regulatory confidence in these approaches.
2. Continuous analysis: A “continuous inference engine” will enable real-time or on-demand analyses that remain statistically valid as data accumulate. This would support timely trial adaptations and reduce reliance on large conventional control groups.
3. Trial operations: An “agentic operations layer” will use AI agents to automate key startup and operational tasks, help incorporate new treatment arms, and accelerate data collection, cleaning and preparation for analysis.

ARPA-H is seeking multidisciplinary teams with expertise spanning statistics, AI, trial design, operations and regulation. The program is currently inviting proposals, so the anticipated improvements remain objectives to be demonstrated.

SURPASS comes alongside a wider set of US government initiatives to modernize clinical research. These include Operation TrialBlazer, announced by HHS in June 2026 to strengthen domestic research capacity and attract investment. Under this initiative, the FDA has launched an expedited pilot for investigational new drug applications to support faster entry into first-in-human trials and revised draft guidance on master protocols, including platform trials. SURPASS complements these efforts by supporting the development of technology and statistical methods for new trial approaches.

In early October 2026, the FDA has also established its Office of Innovation and Clinical Trial Modernization, bringing together dedicated divisions for AI and RWE analytics alongside the Clinical Methodology Staff.