The federal government wants to change how new medicines are tested in people. On Sept. 30, the U.S. Department of Health and Human Services announced SURPASS, a program run by the Advanced Research Projects Agency for Health (ARPA-H) that aims to use computer simulations, digital twins, real-time data analysis, and automation to test drugs and biologics faster, at lower cost, and with fewer participants.
The HHS announcement, made in Austin, Texas, also introduced three companion projects meant to add trial sites, build a national research data system and help patients share their own health records with researchers. What the release leaves out matters just as much. It names no budget, no target diseases, and no detailed patient privacy rules for SURPASS itself.
For families, the stakes are practical. Many people with cancer or rare diseases look to clinical trials for access to treatments not yet on the market, yet trials are often far from home and slow to open. If the program works as described, more patients could find trials closer to where they live.
Phaseless Trials and Digital Twins Explained
Drug testing today moves through separate phases, each with its own setup. HHS says this process "often takes more than a decade, costs up to $2 billion on average, and fails more than 90 percent of the time."
SURPASS stands for Simulation-augmented, Real-time Platform Adaptive Seamless Trials. According to HHS, it will fund work in three areas. The first is a "phaseless design engine" that uses digital twins (computer models that predict how a patient or group of patients might respond) to simulate trial outcomes before a study begins. The second is a "continuous inference engine" that analyzes results as data arrive and reduces the need for large conventional control groups. The third is an "agentic operations layer" that automates trial startup, data collection, and data 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, Ph.D., said in the release.
Fedyukina set ambitious targets in an interview with Axios. "There's no reason why we cannot cut timeline in half or more," she said, adding that the program could target "a 10x reduction in the cost of clinical development for a drug."These are goals, not results. No SURPASS trial has run yet, and the approach still has to earn the confidence of regulators.
HHS Secretary Robert F. Kennedy Jr. cast the effort as a fix for slow, costly trials. "HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down," he said in the release. The push also comes as China gains ground in drug research. BioPharma Dive reported that China surpassed the U.S. share of Phase 1 trials in 2021 and registered more total clinical studies in 2024.
Dell Medical School Anchors Two Companion Projects
According to UT News, Dell Medical School at the University of Texas at Austin is the key academic partner on two companion projects. STACK aims to expand the number of sites equipped to run clinical trials, and HHS says that includes converting sites with no research experience. COMMONS will build a national research data resource governed by patient and institutional permissions, with Dell Med as the first contributing site.
UT noted that travel, missed work, caregiver duties, and repeated visits can make taking part in a trial difficult or impossible for patients. Kennedy echoed that point in Austin, telling the audience that the current system "takes far too long, it costs too much, and it asks too much of the patients," KUT reported.
Dell Med Dean Claudia Lucchinetti, M.D., stressed safeguards. "Scientific rigor and patient protections must guide every step, so patients and clinicians can have confidence in the findings that inform their decisions," she said in the UT release.
The third project, CINCH, focuses on patients. "Patients don't just participate in clinical trials; their real-world data and experiences are needed to power them," said Erika Kim, Ph.D., the ARPA-H program manager who oversees CINCH, in the HHS release. Axios reported that CINCH will help patients with complex cancers use their own data within the health system.
Missing Budget, Diseases and Privacy Details
Several key questions remain open after a review of the HHS release and the ARPA-H program page. Neither source lists a dollar amount for SURPASS or the number of teams it will fund. STAT also reported that no funding figure was disclosed. Axios reported that winning teams will receive support over five years.
Neither page says which diseases SURPASS trials will target. HHS said only that the tools could help sponsors and regulators "across many diseases." The program also has not explained how individual patients would join a SURPASS trial or how a digital twin built from their data would be stored and protected.
On privacy, HHS describes COMMONS as a "privacy-by-design architecture for consent at national scale." That is a stated design goal, not a published policy. The public materials do not yet explain who can access the data, how long it is kept or how patients can withdraw consent. ARPA-H says fuller details are in the solicitation documents posted on SAM.gov.
Smaller control groups can save time, but regulators will want proof that results stay reliable. Fedyukina told Axios the FDA took part in planning and that "there won't be any surprises for regulators in this."
SURPASS is a research funding program, not a new rule, and it does not change how existing studies run. Anyone weighing a trial can search ClinicalTrials.gov and talk with a clinician about eligibility, travel costs, and who pays for study-related care. Do not stop prescribed medication to join a study without speaking with a health care professional.
The next steps are set. ARPA-H lists an informational webinar on Oct. 15, a Proposers' Day on Nov. 6, required solution summaries due Nov. 30, and full proposals due Jan. 22, 2027. For now, SURPASS is a plan with ambitious goals, and patients and families should watch for the funding, disease, and privacy details that will decide whether it reaches them.
Key Questions Answered
What is SURPASS?
SURPASS is an ARPA-H program announced by HHS on Sept. 30 that will fund teams to build AI tools, digital twins, and real-time analysis methods for faster, cheaper clinical trials with fewer participants.
What is a digital twin in a clinical trial?
It is a computer model that predicts how a patient or group of patients might respond. SURPASS plans to use such models to simulate trial outcomes before a study starts.
How much money is the government spending?
HHS and ARPA-H have not publicly disclosed a funding amount. Axios reported that selected teams will receive support over five years.
Can patients sign up for a SURPASS trial now?
No. ARPA-H is still collecting proposals, with full proposals due Jan. 22, 2027. People interested in current studies can search ClinicalTrials.gov and talk with their clinician.
What role does Austin play?
Dell Medical School at UT Austin is the key academic partner on STACK and COMMONS and will be the first site to contribute data to COMMONS.
Is patient data protected?
HHS says COMMONS is designed with privacy built in, but detailed rules on data access, storage, and consent withdrawal have not been published.
Published by Medicaldaily.com
