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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 Services (HHS) known as “Operation Trailblazer,” could reduce early trial timelines by six to 12 months, officials said. The FDA also issued guidance clarifying that one high-quality late-stage clinical trial with confirmatory evidence will be sufficient to support approval in many cases.
During a call with reporters Monday, officials described the sweeping plan as necessary to counter the threat from China.
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A growing share of early-stage clinical research has moved overseas, HHS said in a statement, threatening America’s position as the global leader in biomedical innovation.
China now conducts more clinical drug trials than the U.S. Costs are low, regulation is streamlined and the Chinese government offers subsidies to companies that make it hard for other countries to compete. Researchers cite a law that traded drug price cuts for inclusion into China’s national insurance program.
“We’ve been witness to a growing share of phase 1 clinical trials moving overseas, delaying opportunities for American patients and weakening the nation’s position as a global leader in biomedical research,” acting FDA Commissioner Kyle Diamantas said. “FDA is taking action to reverse that trend.
Faster clinical trial development was a priority of former FDA Commissioner Marty Makary before he resigned last month, but officials on Monday said the program had been in the works since the start of the second Trump administration.
The FDA historically has required two late-stage trials for companies to prove the safety and efficacy of their drugs, but the agency has become more flexible recently.
In a Fox News op-ed, Health Secretary Robert F. Kennedy Jr. wrote that the U.S. is “losing ground” to China in clinical research.
“America should not lose clinical research because of barriers that we have the power to remove,” Kennedy wrote.
In 2021, China’s global share of Phase 1 trials surpassed the United States’ share for the first time. In 2024, China surpassed the United States in the total number of clinical trials registered, with 39 percent of global trials.
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