FDA to launch pilot program to speed up early-stage clinical trials
Health officials tout effort to develop drugs more quickly, compete with China.
STAT NEWS
By Chelsea Cirruzzo and Lizzy Lawrence
June 22, 2026
WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they say will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field.
The pilot comes as the Food and Drug Administration, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. That proposal was championed by former FDA Commissioner Marty Makary before he resigned last month, though officials said on a Monday morning call that this program had been in the works since the start of the administration.
In a Fox News op-ed, health secretary Robert F. Kennedy Jr. wrote that the U.S. is “losing ground” against China in clinical research and touted the actions as a way to reverse that trend.
“We are modernizing outdated processes that slow innovation and rebuilding the foundation for the next generation of medical breakthroughs,” he wrote.
Acting FDA Commissioner Kyle Diamantas told reporters that the FDA will issue guidance reaffirming that a single, high-quality Phase 3 trial supported by confirmatory evidence is enough to allow drug approval.
The FDA historically has required two Phase 3 trials for added assurance of a drug’s safety and efficacy, but it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. STAT first reported on the agency’s plans to default to one trial after a December interview with Makary. Patient safety experts told STAT at the time that the change might needlessly lower the agency’s standards.
The FDA also plans to release guidance on dose selection, support for program participants aimed at accelerating first-in-human studies, and clarity on approval pathways. Officials also said they hope to get interest from a wide range of research institutes, including academic medical centers and private centers and said submissions will be reviewed on a rolling basis. A request for information will be used to gather feedback on the early-stage trial pilot.
The pilot was part of a “department-wide” effort at the Department of Health and Human Services to strengthen the U.S.’s involvement in clinical trials, though details are limited on what other agencies will be doing.
According to officials, the National Institutes of Health, for example, will strengthen its existing clinical trial network to help build out reusable trial infrastructure, with its cancer center specifically looking to improve enrollment in trials. Meanwhile, the Office of the National Coordinator for Health IT will explore “ways to better connect patients with clinical trials through electronic health records,” HHS said in a press release.