Health officials launch clinical trial reforms to counter China threat
Officials said Operation Trailblazer could cut early trial timelines by 6 to 12 months as the agency eases approval rules for late-stage studies.
- On Monday, the Food and Drug Administration launched a new initiative to accelerate early-stage clinical trials, aiming to reduce development timelines and reverse the trend of companies moving operations to China.
- Data from the Cure Innovation Index shows a growing translation gap, with China now claiming 32 percent of global clinical trial starts compared to just 1 percent in 2009.
- Acting FDA Commissioner Kyle Diamantas announced the "Operation Trailblazer" pilot program, which could reduce early trial timelines by six to 12 months, while the agency now allows single high-quality late-stage trials for approval.
- "We've been witness to a growing share of phase 1 clinical trials moving overseas," Diamantas said, noting that shifting research weakens America's position as global leader in biomedical innovation.
- Industry leaders emphasize that maintaining leadership requires modernizing clinical trial infrastructure and restoring federal research funding, which 81 percent of survey respondents identified as the highest policy priority.
10 Articles
10 Articles
Health officials launch clinical trial reforms to counter China threat
The Food and Drug Administration (FDA) on Monday launched a new initiative to speed up early-stage clinical trials as part of an effort to reduce development timelines and reverse a growing trend of companies moving overseas, primarily to China. The pilot program, part of a broader initiative across the Department of Health and Human…
Health Officials Announce Plan to Move Clinical Trials Back to United States
The Trump administration is launching an effort aimed at bringing clinical trials back to the United States, after years of more trials moving overseas, according to a June 22 announcement from the Department of Health and Human Services (HHS). HHS and some of its divisions, such as the Food and Drug Administration (FDA), are involved in the new effort, dubbed Operation TrialBlazer. One of the steps is an FDA solicitation of public comments on a…
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