STAT+: FDA to launch pilot program to speed up early-stage clinical trials
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- FDA announced a pilot program Monday to speed up early-stage clinical trials, projecting it will reduce development timelines by six to 12 months and help bring trials back to the U.S.
- The pilot accompanies the president's 2027 fiscal budget request for Congress to establish a permanent faster process for the existing Investigational New Drug pathway.
- Former FDA Commissioner Marty Makary championed the permanent-process proposal before resigning last month, though current officials said the pilot had been in development since the start of the administration.
- HHS Secretary Robert F. Kennedy Jr. wrote in a Fox News op-ed that the U.S. is "losing ground" against China in clinical research and positioned the pilot as a countermeasure.
- Federal health officials explicitly framed the program's goal as encouraging U.S.-based trials and combating Chinese dominance in the field.
Why it matters: Drug developers stand to compress Phase 1 timelines by up to a year, potentially accelerating first-in-human studies in the U.S. The framing of China as the competitive threat — voiced by RFK Jr. and embedded in the pilot's stated mission — signals clinical trial policy is now part of the U.S.-China biomedical race, and the program's continued rollout after Makary's resignation shows it has institutional momentum beyond one commissioner.
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