ARPA-H launches the SURPASS competition to build shared clinical trial infrastructure, aiming to cut the path from first-in-human testing to market from a decade to four years
ARPA-H launches the SURPASS competition to build shared clinical trial infrastructure, aiming to cut the path from first-in-human testing to market from a decade to four years
On September 30, the U.S. Department of Health and Human Services, through ARPA-H, its agency for high-risk biomedical research, announced SURPASS, a five-year competition for biostatisticians, AI developers, and clinical trial specialists to build a shared platform for testing new drugs. Today, that process takes more than a decade on average, costs $1–2 billion, and fails more than 90% of the time.
The current model is sequential: Phase I, Phase II, Phase III, with infrastructure and control groups rebuilt from scratch for each one. Protocols are locked in advance based on assumptions rather than data, and changing them afterward is nearly impossible.
"Today's clinical trial system often requires too many stops, too much duplicated infrastructure, and too much time before researchers know whether a trial is headed in the right direction," says Daria Fedyukina, SURPASS program manager at ARPA-H.
SURPASS targets three points where time and money are currently lost. To keep protocols from relying on guesswork alone, digital twin models simulate the trial in advance and determine patient enrollment numbers on their own. To eliminate waiting for data in batches, continuous analysis reads incoming data in real time and allows the trial to be adjusted on the fly. The launch of each new treatment arm, currently configured manually from the ground up, is handled by automation that collects and cleans the data. The agency also added STACK, COMMONS, and CINCH, which cover new trial sites, shared data resources, and patient engagement.
This shared-platform concept has already proven itself. In 2020, the British RECOVERY trial operated this way, embedded across a hospital network and testing multiple treatments against COVID-19. By the time results came in for the inexpensive steroid dexamethasone, more than 11,500 patients had enrolled. Dexamethasone reduced mortality by one third in patients on mechanical ventilation and by one fifth in those receiving supplemental oxygen only. RECOVERY has since confirmed the efficacy of five drugs and the futility of several others. SURPASS is attempting to extend this same architecture beyond a single sponsor and a single disease to the entire drug development cycle across many companies and conditions, a problem of an entirely different scale.
Within that ambition lies a statistical question the program addresses during trials rather than beforehand: as new treatment arms enter and leave the platform, the shared control group accumulates over time and can distort comparisons if the standard of care shifts or the patient population changes. The New England Journal of Medicine examined this risk in the context of another platform trial, REMAP-CAP. If continuous analysis cannot maintain evidentiary rigor, comparisons against a shared control will not hold up.
For this reason, ARPA-H brought the FDA into SURPASS planning early on. "There will be no surprises for regulators here," Fedyukina told Axios.
SURPASS is one of the first major announcements from ARPA-H under its new director. The Trump administration dismissed founding director Renee Wegrzyn in 2025, and the position went to Alicia Jackson, formerly head of the women's health company Evernow. For now, SURPASS is an open call for ideas, with proposals due by January 2027. It continues an earlier bet on the same bottleneck: ARPA-H is already building PROSPR, a program focused on rapid aging biomarkers. PROSPR seeks ways to determine quickly whether a treatment worked, without waiting decades for outcomes. SURPASS builds the infrastructure capable of delivering that answer fast.