On Wednesday in Austin, Texas, Health Secretary Robert F. Kennedy, Jr. and Alicia Jackson, director of the Advanced Research Projects Agency for Health, will unveil a Trump administration effort to overhaul clinical trials. CMS Administrator Mehmet Oz and FDA Acting Commissioner Kyle Diamantas will join them. The initiative aims to cut the time and expense required to bring new drugs to market.
The program, called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, marks a significant shift in regulatory philosophy. Instead of imposing new mandates, the administration is offering financial incentives and technical support to drug makers willing to test innovative trial designs. Teams chosen through a bidding process will take drug candidates through experimental clinical-trial processes and receive funding and support over five years.
Streamlining the Regulatory Burden
Traditional drug development takes longer than a decade and costs around $2 billion. More than 90% of drug candidates fail, according to HHS data. This burden carries real consequences: China has become a popular location for drug manufacturers in part because early-stage clinical trials there cost less and move faster. The United States can't afford to lose that competitive edge.
ARPA-H is seeking proposals in three technical areas meant to cut unnecessary complexity. The first targets phaseless trials that can move faster with fewer patients. The second focuses on analyzing data in real time during a trial, rather than waiting for it to end. The third aims to automate inefficiencies that have calcified into standard practice.
Program manager Daria Fedyukina said regulators won't be blindsided by the changes. "There won't be any surprises for regulators in this," she said, adding that the FDA took part in planning. The goal isn't deregulation; it's smarter regulation. "We need to develop the tech that is missing and blaze the trail of a new clinical trial paradigm," Fedyukina explained.
The potential impact could be enormous. Fedyukina said the program targets "a 10x reduction in the cost of clinical development for a drug," while cutting timelines in half or more. Those aren't pie-in-the-sky projections; they reflect how outdated processes weigh down trials today. Real-time data analysis and AI-driven site activation aren't science fiction. They already exist in other sectors and are waiting to be integrated into pharmaceutical development.
Infrastructure Investment for Market Competition
ARPA-H will also announce three related projects to strengthen clinical-trial infrastructure. One will establish more trial sites, using AI to speed site activation and prepare hospitals that haven't previously held trials. Patients near hospitals that don't currently participate in trials will gain access to experimental drugs. Those hospitals, in turn, can capture revenue and expertise.
The other two projects focus on clinical-trial data infrastructure and helping patients with complex cancers use their own data to navigate the care system more effectively. Rather than centralizing control, the initiatives put capability and information where they can do the most good.
Experts and the biopharmaceutical community largely agree that the United States needs to streamline trial processes to remain competitive. This approach does so through collaboration, not coercion. Drug sponsors, medical centers, biostatisticians, and predictive-modeling companies will all have skin in the game. The FDA gets transparency and standards without strangling innovation.
Why This Matters:
The pharmaceutical industry is a cornerstone of American competitiveness and prosperity. If we lose the race to develop and commercialize drugs, we lose jobs, investment, and the ability to treat American patients with cutting-edge therapies. The SURPASS program acknowledges a hard truth: outdated trial processes don't protect patients; they delay treatments while competitors abroad move faster. By creating market incentives for innovation in trial design and setting clear standards regulators understand upfront, the initiative removes barriers without abandoning safety oversight. That's governance that respects both individual liberty and institutional responsibility. The five-year funding commitment signals serious intent. Success here could help American pharma reclaim ground lost to international competitors while preserving the rigorous standards that keep treatments safe and effective.