HHS launches ARPA-H project to speed clinical trials
The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program. The program aims to transform how clinical trials are designed and conducted to streamline them and ultimately bring products to market sooner.
On Wednesday, HHS announced the program, which will use advanced computational models, real-time analysis, shared infrastructure, and automation to evaluate drugs and biologics faster, more cheaply, and with fewer participants.
In the coming months, ARPA-H will host two events for interested parties to learn more about the opportunity; solicitation summaries are due by the end of November and full proposals should be submitted by 22 January 2027, though the agency has not set out a timeline for when it will make selections for the program.
While the US Food and Drug Administration (FDA) is the regulatory agency responsible for ensuring clinical trials are conducted adequately, ARPA-H has been tasked by Congress to investigate breakthrough technologies, platforms, capabilities, resources, and solutions that have the potential to make significant differences in medicine and health that aren't doable through traditional research and commercial activity.
"HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down," HHS Secretary Robert Kennedy Jr. said. "Through ARPA-H, we are building a modern clinical trial system that can generate rigorous evidence faster, reduce the burden on patients, and move effective treatments from discovery to the people who need them sooner."
HHS noted that under the current clinical trial system, drugs and biologics can take decades to reach the market and cost an average of $2 billion to develop. The department also highlighted that despite investments of time and money, 90% of such products ultimately fail, meaning that in many cases, promising new treatments never see the light of day because they are too costly and face too many hurdles.
"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," said SURPASS Program Manager Daria Fedyukina. "SURPASS is developing the technology and biostatistical frameworks needed to analyze trial data as it accumulates, allowing teams can [sic] learn in real time, adapt when needed, and generate stronger evidence faster with less operational burden."
Kennedy has stated that the US is losing its leadership position in hosting clinical trials and the economic activities associated with them, most notably to China. In recent months, the department has taken steps, such as launching Operation TrialBlazer, to expedite certain clinical trials. (RELATED: HHS and FDA propose clinical trial reforms to expedite drug development, Regulatory Focus 23 June 2026)
"America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas," said Kennedy in a press release announcing Operation TrialBlazer.
"America led the world in medical innovation before," he added. "We will lead again."
HHS said that SURPASS aims to address those challenges by building continuous, adaptive platform trials that combine predictive computational models, shared trial infrastructure, common control groups, and real-time analysis to promote efficient clinical trials and encourage more patients to participate.
More specifically, HHS said SURPASS will build a phase-less design engine for faster trials with fewer patients, using digital twins and predictive models to simulate clinical and operational outcomes. The department stated that outputs from the design engine may be used to support regulatory interactions but must adhere to certain FDA guidances, including its guidance on adaptive design in clinical trials and on interacting with the agency when using complex innovative trial designs. When analyzing data, they also need to comply with FDA's guidance on using Bayesian methodology in clinical trials for drug and biological products.
"Simulation tools, assumptions, code, and outputs used to support regulatory decision-making must be documented and shareable in a form that allows regulators to understand, reproduce, and interrogate the design," said HHS.
The agency said the program will also develop a continuous inference engine to allow valid, real-time or on-demand analysis that will help speed clinical decision-making. It said the continuous inference engine will allow researchers to quickly adapt trials and reduce the need for large conventional control groups.
Finally, SURPASS will have an agentic operations layer to automate key clinical trial startup and operational activities, onboard new treatment arms, and accelerate data collection and processing. Ultimately, HHS said it will also help reduce time and clinical trial costs.
HHS said that, in addition to SURPASS, ARPA-H will conduct three complementary projects aimed at addressing critical clinical trial infrastructure challenges, including using artificial intelligence to start clinical trials faster, expand capacity, and create more domestic clinical trials through a program called STACK. The agency will also conduct a project called COMMONS to create a privacy-by-design architecture for consent at the national scale and to allow access to regulatory-grade data, and another project called CINCH to allow patients to submit real-world data, with benefits such as helping them find trials best suited to them.
"Together, these efforts will address multiple barriers that slow clinical development today: outdated trial designs, limited site capacity, fragmented data infrastructure, and a patient experience that is often difficult to navigate," said HHS. "By advancing these efforts in parallel, ARPA-H aims to help build a clinical trial ecosystem that is faster, more connected, more adaptive, and more patient-centered."
