China Tightens Rules on Investigator-Initiated Trials — SkimNews
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- China introduced new government restrictions on investigator-initiated trials, or IITs, and the route to human testing is now less speedy.
- Patient deaths recently reported in China, together with the new restrictions, have slowed investigator-initiated trials.
- China’s human-testing route had been fast and inexpensive before the controls, but is now described as considerably less speedy.
- U.S. biotechs were eager to use IITs to bypass lengthy development timelines; the source describes the slowdown as falling ‘perhaps to their chagrin.’
- Jason Mast reported that the restrictions and patient deaths had slowed IITs, with the detailed account exclusive to STAT+ subscribers.
Why it matters: U.S. biotechs are the clearest stakeholders: two developments—new Chinese government restrictions and reports of recent patient deaths—have slowed investigator-initiated trials. The direct consequence is less speed for companies using the route to reach human testing sooner and bypass lengthy development timelines.
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