HHS Initiative Aimed at Cutting Drug Development to Under 4 Years

HHS’ Advanced Research Projects Agency for Health has launched a funding initiative aimed at dramatically shortening clinical development of drugs and biologics through adaptive platform trials, artificial intelligence, and real-time data analysis.

The “Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)” program is seeking technologies and trial approaches that could reduce clinical development timelines from more than a decade to less than four years, while lowering costs and requiring fewer participants.

ARPA-H notes that the current clinical development model remains fragmented, with separate trial phases requiring repeated study startups, static trial designs and duplicated operational infrastructure. The agency estimates drug and biologic development frequently can cost between $1 billion to $2 billion and fails about 90% of the time.

“SURPASS seeks to build perpetual, adaptive platform trials that combine 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,” an ARPA-H notice says. The goal is to allow investigators to make earlier decisions about whether therapies are working and modify trials as evidence emerges.

“ARPA-H is seeking ground-breaking ideas from cross-disciplinary teams in statistics, AI, and clinical trial design, operations, and regulation,” the notice says. “Teams will pursue three coordinated technical areas to build faster trials with fewer patients, develop a continuous inference engine for faster decisions, and create an agentic operations layer to reduce time and cost.”

The initiative could have significant regulatory implications because seamless and adaptive trials would need to generate evidence capable of supporting FDA decision-making. ARPA-H said one objective is to bring regulatory-science expertise together with trial designers and technologists to develop shared infrastructure and new standards.