The Trump administration is launching an effort to redesign clinical trials and sharply cut the time and money needed to develop new drugs. Drug sponsors will join teams competing for government support. Health Secretary Robert F. Kennedy, Jr. and Advanced Research Projects Agency for Health Director Alicia Jackson will unveil the project in Austin, Texas, on Wednesday. CMS Administrator Mehmet Oz and FDA Acting Commissioner Kyle Diamantas will also attend.
Who Gets the Funding
The program, called Simulation-augmented, Real-time Platform Adaptive Seamless Trials, or SURPASS, is being developed under ARPA-H. Teams that include a drug sponsor will submit proposals through a bidding process. Those chosen will test drug candidates through experimental clinical-trial processes and receive funding and support over five years.
ARPA-H wants proposals in three technical areas: phaseless trials designed to move faster with fewer patients; real-time analysis of trial data rather than waiting for a trial to end; and automation to reduce inefficiencies. Teams will likely also include medical centers or other clinical sites, biostatisticians and companies that predict drug outcomes by computer.
Program manager Daria Fedyukina said the project aims “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 Cost and Time Target
Developing a drug can take longer than a decade and cost around $2 billion, according to HHS. More than 90% of drug candidates fail, the department said. Fedyukina said it was hard to quantify possible savings, but added, “there is no reason why we cannot target, let's say, a 10x reduction in the cost of clinical development for a drug.” She also said, “There's no reason why we cannot cut timeline in half or more.”
The effort comes as China has become a popular place for drug manufacturers, partly because early-stage clinical trials there cost less and move faster. Experts and the biopharmaceutical community largely agree that the United States needs to streamline trial processes to compete.
The FDA helped plan SURPASS. “There won't be any surprises for regulators in this,” Fedyukina said. Under the announced process, selected teams will test drug candidates using experimental trial methods. The FDA will take part in planning, and the program’s proposed standards are intended for other U.S. trials.
Sites, Data and Patient Access
ARPA-H is also announcing three related projects to improve clinical-trial infrastructure. One will establish more trial sites, using artificial intelligence to speed site activation and prepare sites that haven't held trials before.
That project could give patients near hospitals that don't currently participate 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 announcement lays out proposed changes to trial design, data analysis, automation and site preparation. It doesn't quantify the savings the program may produce; Fedyukina described a tenfold cost reduction and halving timelines as targets. Selected teams will receive funding and support over five years.