China’s investigator-initiated trials (IITs), which accelerate testing of new therapies, are under scrutiny following recent deaths. The trials have driven growth in China’s biomedicine sector, particularly in cell and gene therapies, but have also faced issues with oversight and inconsistent standards.
IITs are a popular method for researchers and biotech companies to test new therapies, and are faster than the standard drug-approval system supervised by the National Medical Products Administration. The number of annually registered IITs in cell and gene therapy grew 11-fold, from 2015 to 2023, reaching 207. These trials also occur in the United States, but require approval from the FDA.
The increased attention to IITs comes after the government implemented stricter rules for these trials on May 1st, known as Order 818. Researchers and industry insiders state the regulations aim to increase government oversight while still encouraging innovation. Dai Jialing, president of PharmaDJ, a Shanghai-based business intelligence company, explains IITs often determine if larger clinical studies are worthwhile.
Previously, rules required stem-cell therapy IITs to be conducted at China’s top research and training hospitals, known as “sanjia.” However, Iris Zhang, a lawyer at Han Kun Law Offices in Shanghai, notes that much cell-therapy activity occurred in non-sanjia institutions, private clinics, and affiliated ventures due to inconsistent supervision. This led to a grey market with unauthorized or fraudulent therapies, resulting in medical accidents and deaths.
Order 818 governs IITs using new biomedical technologies, including cell therapies, brain implants, and gene editing treatments. Hao Bin, an economist at Xi’an Jiaotong-Liverpool University in Suzhou, China, says the order’s purpose is to increase regulatory oversight. Under the new rules, only sanjia hospitals are permitted to conduct IITs for all new biomedical technologies. Ruby states these hospitals have the “best clinicians, the best researchers, the greatest access to patient populations” and are the “most reliable, trustworthy institutions to deliver research, adding safeguards for patients.”
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