China's Clinical Trials Slow Under New Rules — SkimNews
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- Huangxi could no longer stand or walk at 16 months in 2014; Chinese doctors had no answers, and it took two years and a flight to Massachusetts to diagnose her genetic disease, with Boston Children’s Hospital offering no treatments.
- Chinese hospitals became sophisticated centers for diagnosing and treating rare disease over the following decade, after doctors there initially lacked answers for Huangxi’s condition.
- Hope for Rare Foundation helped push genetic treatments into trials at a fraction of U.S. costs and was on track to start two more trials until this summer, when deaths, news reports, and new government rules upended those plans; Huang said the government had become “very strict.”
- Investigator-initiated trials (IIT) allowed investigators in China to begin human clinical trials without central-regulator sign-off; the looser rules enabled Chinese companies to test drugs faster and more cheaply.
- U.S. companies responded to China’s loosened IIT rules by coming to China or pushing the Food and Drug Administration to adopt a similar approach.
Why it matters: For Hope for Rare Foundation, two more planned trials were upended this summer, and Huang said the government had become “very strict.” The route that let investigators launch tests without central sign-off had enabled faster, cheaper trials for Chinese companies and prompted U.S. firms to enter China or push the FDA, directly altering the foundation’s trial pipeline.
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