The U.S. Department of Health and Human Services (HHS) announced the launch of a new program aimed at removing barriers that slow clinical development and transforming how clinical trials are designed and conducted.
HHS announced the program on Sept. 30 as Surpass—simulation-augmented, real-time platform adaptive seamless trials. The work will take place through the Advanced Research Projects Agency for Health (ARPA-H), although the release did not share exact details on the scope, saying only that it will address clinical trial barriers using predictive computational models, shared trial infrastructure, common control groups, and real-time analysis to enable earlier, smarter decision making that will help speed effective drugs to patients.
“We want to move from a system built around disconnected trials, repetitive processes and fragmented data to one built around reusable infrastructure, secure information, adaptive research, and wider patient access and easier patient recruitment,” HHS Secretary Robert Kennedy Jr. said during the Sept. 30 live announcement.
Alongside the Surpass program, ARPA-H is also launching three complementary projects, two of which are in collaboration with the University of Texas at Austin Dell Medical School.
The Stack project aims to use artificial intelligence to accelerate clinical site activation and convert research-naïve sites into clinical trial sites capable of running studies. Commons will create an architecture for consent at a national scale to enable access to regulatory-grade data. The Cinch program will focus on patient empowerment and care navigation, with an emphasis on cancer patients.
Together, all the initiatives aim to speed up the clinical trial system by modernizing clinical development, reducing delays and costs and strengthening U.S. competitiveness in biotechnology and drug development.
“The four major efforts today, is probably the largest suite of investments that we've made in a singular area,” Alicia Jackson, Ph.D., director of ARPA-H said during the live announcement. “If we don't get this right, who cares if we find the next treatment or cure if it doesn't get through a clinical trial, or it gets developed overseas.”
In June, HHS revealed Operation Trial Blazer, an initiative meant to hasten phase 1 trials and encourage companies to conduct the studies in the U.S. rather than speedier locales like China and Australia. Following this initiative, the Food and Drug Administration opened a pilot program to expedite the investigational new drug (IND) application process, with the ultimate goal of reducing phase 1 trial timelines by six months to a year.
“We're in a crisis now, and the president's made it really clear that we're losing the race,” Secretary Kennedy said during a live announcement. “China is now doing more clinical trials than we are. It's not just economic benefits that we're losing—it's the control of our healthcare, our health and our international leadership in biomedical research.”