The Trump administration is launching a federal project to redesign clinical trials, with drug sponsors built into teams competing for funding and support. The effort, called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, will take shape under the Advanced Research Projects Agency for Health (ARPA-H). Health Secretary Robert F. Kennedy, Jr. and ARPA-H Director Alicia Jackson will unveil it in Austin, Texas, on Wednesday. CMS Administrator Mehmet Oz and FDA Acting Commissioner Kyle Diamantas will also attend.
The program brings public agencies, regulators and drug developers together to set a new trial model. Teams chosen through a bidding process will test drug candidates in experimental clinical-trial processes and receive funding and support over five years. Each team must include a drug sponsor. Medical centers or other clinical sites, biostatisticians and companies that use computers to predict drug outcomes will likely take part, too.
Patients and community groups don’t appear in the account as quoted voices, and it describes no patient-led or community-run response to the project. Instead, agencies and selected teams that include drug sponsors are shaping the program’s design.
The state sets the trial blueprint
ARPA-H is seeking proposals in three technical areas: phaseless trials that can move faster with fewer patients; real-time data analysis during a trial rather than only after it ends; and automation to cut inefficiencies. The FDA took part in planning. “There won't be any surprises for regulators in this,” said program manager Daria Fedyukina.
Fedyukina said the goal is “to develop the tech that is missing and blaze the trail of a new clinical trial paradigm.” She said the program will require “blueprints and standards that then can be deployed and used by all other trials in the U.S.” The plan reaches beyond teams receiving support: other U.S. trials are meant to use the standards developed through the program, too.
How much money the effort might save remains unclear. Fedyukina said it was hard to quantify, but “there is no reason why we cannot target, let's say, a 10x reduction in the cost of clinical development for a drug.” She added, “There's no reason why we cannot cut timeline in half or more.” Those remain targets, not reported results.
The cost of the existing machinery
According to HHS, developing a drug can take longer than a decade and cost around $2 billion, while more than 90% of drug candidates fail. Those figures show the scale of the investment and risk surrounding drug development. The article doesn’t say how any savings would be distributed among drug companies, patients or trial sites.
China has become a popular location for drug manufacturers partly because early-stage clinical trials there cost less and move faster, the article said. Experts and the biopharmaceutical community largely agree that the United States needs to streamline trial processes to compete. Competition is part of the argument for changing how the system runs.
ARPA-H is also announcing three related projects to improve clinical-trial infrastructure. One will establish more trial sites, using AI to speed site activation and prepare sites that have not previously held trials. That could give patients near hospitals that don’t currently take part in trials access to experimental drugs. The other two projects focus on clinical-trial data infrastructure and helping patients with complex cancers use their own data and better navigate the care system.
The announced projects could provide some patients with a path to trial access, especially those near hospitals outside the current network. But the account describes no direct action or mutual-aid effort. The response on offer is institutional, organized through federal programs, selected teams and the clinical sites they aim to prepare.