Health Secretary Robert F. Kennedy, Jr. unveiled a major overhaul of U.S. drug trials on Wednesday, betting that faster, cheaper research could open access to experimental medicines and help American pharmaceutical companies compete globally.
The initiative, called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, aims to cut development timelines and costs that keep most patients from breakthrough treatments. Developing one drug takes more than a decade and costs around $2 billion, according to the Department of Health and Human Services. More than 90% of drug candidates fail before reaching patients.
ARPA-H, the advanced research agency within HHS, will fund selected teams for five years as they test new trial designs. Advanced Research Projects Agency for Health Director Alicia Jackson and CMS Administrator Mehmet Oz joined Kennedy and FDA Acting Commissioner Kyle Diamantas at the announcement in Austin, Texas.
The Cost Barrier to Treatment Access
Most Americans can't take part in clinical trials. Trials cluster at major academic medical centers, far from rural communities and underserved areas. Millions who might benefit therefore can't access experimental drugs. ARPA-H is taking on the problem directly. One companion project will use artificial intelligence to open trial sites faster and prepare hospitals that have never run trials. That could put experimental treatments within reach of patients near community hospitals that don't currently participate in research.
Program manager Daria Fedyukina set out ambitious targets. “There's no reason why we cannot target, let's say, a 10x reduction in the cost of clinical development for a drug,” she said. She added, “There's no reason why we cannot cut timeline in half or more.”
SURPASS focuses on three technical changes: phaseless trials that move faster with fewer patients; real-time data analysis during trials, rather than only after they end; and automation to remove inefficiencies that slow research. The FDA helped plan the effort so regulators won't face surprises as the new approaches advance.
Why the Shift Matters Now
The United States is falling behind. China has become a popular place for early-stage clinical trials, partly because trials there cost less and move faster. American experts and the biopharmaceutical industry agree the nation must modernize or surrender research leadership. ARPA-H is also announcing two other projects: one to improve clinical-trial data infrastructure, and another to help patients with complex cancers navigate the system using their own health information.
Fedyukina recognized how hard it is to calculate savings upfront. But the program won't be judged on cost reductions alone—it will also be measured by how many more patients get treatments that could extend their lives. Selected teams will include drug sponsors, medical centers, biostatisticians, and companies that can predict drug outcomes by computer. Teams with winning proposals will receive funding and technical support.
Why This Matters:
Clinical trials expose a basic equity problem. When trials cost too much and move too slowly, they cluster in wealthy regions with established research infrastructure. Patients in rural areas, low-income communities, and underserved neighborhoods rarely get the chance to enroll in studies of promising new drugs. SURPASS aims to lower costs and expand trial sites, directly addressing who gets access to innovation. If it works, breakthrough treatments could reach patients faster, regardless of geography or wealth. Its focus on real-time data analysis and automation also reflects the reality that American research can't compete globally while outdated processes weigh it down. For patients and communities long excluded from clinical research, the effort seeks to broaden who benefits from scientific progress and who bears the cost of slower drug development.