The Department of Health and Human Services has launched a five-year effort to redesign clinical trials with the goal of sharply reducing the cost of developing new drugs. The Advanced Research Projects Agency for Health will manage the SURPASS program, with support from the FDA, CMS, medical centers, biostatisticians, technology companies, and drug manufacturers.

Selected teams will test phaseless trials that move faster and require fewer participants, while also analyzing results as research is underway rather than waiting until the end. Automation and computer models will predict drug outcomes and reduce delays in trial administration. The winning teams will receive funding and technical support.

HHS says bringing a drug to market often takes more than a decade and costs about $2 billion, while over 90% of candidates fail. Program leaders believe a new trial system could cut development timelines by half and reduce costs tenfold. Related projects will expand trial locations, improve data infrastructure, and help patients with complex cancers use their medical information to find treatments.

Expensive trials put a noticeable cap on how many treatments companies can afford to pursue. A promising drug may be abandoned when testing requires years of recruitment, paperwork, and repeated study phases. Lowering those costs could let manufacturers investigate treatments for smaller patient populations that offer less commercial return.

The American system has a strategic disadvantage in drug research, especially compared with countries like China, which often attracts early-stage drug research because trials can be conducted faster and much more cheaply. Building a more efficient American system has substantial upside, specifically when it comes to keeping investment, talent, and manufacturing closer to home while reducing dependence on foreign research networks.

However, speed cannot come at the expense of reliable evidence. Computer simulations and smaller trials must still identify dangerous side effects and show whether a treatment works across different populations. FDA participation could help new methods meet regulatory requirements without repeating work later.

SURPASS will be a consequential test of whether the United States can remove administrative waste from drug development while preserving the standards that ultimately protect American patients from ineffective or unsafe medicines.

Patients who have exhausted treatments may soon gain another option, as expanding trial sites beyond research hospitals would make enrollment realistic for people who cannot travel for scans and follow-up visits. Real-time analysis could sooner reveal the overall effectiveness of a drug, allowing doctors to move patients to alternatives instead of leaving them in a failing study arm.

SURPASS will not set new drug prices or require insurers to cover a new treatment. Its influence comes much earlier by reducing the expense and delay that prevent many drug candidates from reaching patients. Having a larger pipeline could give doctors more therapies to consider for patients rather than relying on a few costly options. While increased competition may improve pricing and coverage over time, the program ultimately cannot guarantee either result.