Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
Agentic twins. Phaseless design engine. Fewer trial participants. All these are part of the U.S. government’s new efforts to secure global leadership in clinical research.
Unveiled by the Advanced Research Projects Agency for Health (ARPA-H), the initiative is designed to speed up clinical trials and slash patient burden, according to a Wednesday release from the U.S. Department of Health and Human Services (HHS).
The new program will be known as Simulation-augmented, Real-time Platform Adaptive Seamless Trials, or SURPASS. The initiative will incorporate advanced computational models, real-time analysis and automation “to evaluate drugs and biologics faster, at lower cost, and with fewer participants,” according to the government release. “By enabling more efficient designs, the program will allow more patients to participate in trials that are more likely to benefit them.”
The effort comes the same week that President Donald Trump signed an executive order to establish an AI-powered chatbot to streamline user experience across government services.
The new ARPA-H program will focus on three key areas, the first of which is building “a phaseless design engine for faster trials with fewer patients” by integrating digital twins and other predictive models into trial design and simulating outcomes before launch.
SURPASS will also develop “a continuous inference engine for faster decisions . . . reducing the need for large conventional control groups while maintaining rigorous evidence generation.”
Lastly, SURPASS is to “create an agentic operations layer” that will automate trial startup and operational activities, supporting onboarding for new treatment arms and speeding up data collection and cleaning.
“Today’s clinical trial system often requires too many stops, too much duplicated infrastructure, and too much time before researchers can understand whether a trial is on the right track,” SURPASS program manager Daria Fedyukina said in a prepared statement. “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.”
Beyond SURPASS, ARPA-H has also announced three other complementary projects aimed at removing barriers to clinical development.
One project, dubbed STACK, will use AI to “accelerate clinical site activation and convert research-naïve sites into clinical trial sites capable of running studies.” The goal is to improve patient accessibility to these studies.
Meanwhile, COMMONS will create a national consent architecture to enable data access across the U.S. clinical trial ecosystem.
Then there’s CINCH, which is focused on “patient empowerment and care navigation” by helping patients contribute their own real-world data.
“America should lead the world in turning medical breakthroughs into treatments for patients,” said HHS Secretary Robert F. Kennedy Jr. “HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down.”
Launched by the Biden administration in 2022, ARPA-H initially secured $1 billion from Congress to bankroll high-potential, high-impact biomedical research. In February 2025, inaugural ARPA-H leader Renee Wegrzyn was let go by the Trump administration, according to Fierce Biotech. In October, Evernow CEO Alicia Jackson was tapped to lead the unit.
The latest ARPA-H efforts come as the U.S. “risks losing clinical trial leadership and the economic activity that comes with it,” according to the Wednesday release.
Industry concerns have grown louder over the past few years about other countries’ increasing prowess in biotech—particularly China. Six years ago, the Asian country surpassed the U.S. in terms of the number of clinical trials, with the U.S. also falling behind in R&D funding and translational science since then.
“China’s approach has been to steal, scale and strangle American competitors in this space,” Caitlin Frazer, executive director of the National Security Commission on Emerging Biotechnology (NSCEB), told BioSpace in August. “We have to start thinking about what it means if we so erode our innovation base here in the U.S. that we are dependent on a potential adversary for life-sustaining medications.”
The new ARPA-H rollout follows the HHS-wide Operation TrialBlazer Initiative, which included an FDA pilot program intended to reduce the time and burden to move assets into first-in-human studies. That program opened for applications last month and will remain open until Oct. 30.
These initiatives come after the FDA downsized by more than 3,000 staffers last year, many of which were layoffs or incentivized early retirements. This year, the agency has said it wants to hire some 2,200 staffers, including some of the recently departed employees.
The federal agency has undergone massive changes under Trump’s second administration, ranging from leadership shake-ups to widespread cuts. In the summer of last year, the agency rolled out Elsa, an AI tool designed to boost efficiency. At the time, many experts called for the FDA to provide more details about how the model works and what benchmarks, if any, the agency has for evaluating its output.
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