GoKawiilUnder China’s Order 818, only high-level hospitals will be able to conduct investigator-initiated trials (IITs).Credit: Xinhua/Shutterstock
In the past two months, reports that two children died after receiving gene-editing treatments in separate clinical trials in China have put a spotlight on the country’s fast-track trial pathway.
Investigator-initiated trials (IITs) are a popular way that researchers and biotech companies test new therapies. Trials are much faster than those required by China’s drug-approval system, which is supervised by the National Medical Products Administration and roughly equivalent to the US Food and Drug Administration (FDA).
IITs are widely considered to be a driving force behind China’s rising competitiveness in biomedicine, particularly for cell and gene therapies, with the number of annually registered IITs in this area growing 11-fold to 207 between 2015 and 20231. These trials also exist in the United States, although they require approval from the FDA.
News of the deaths comes only months after the government introduced stricter rules for IITs of new biomedical technologies. Researchers and industry insiders say that the regulations are designed to spur innovation while increasing government oversight. The regulation, called Order 818, went into effect on 1 May.
What are fast-track trials?
IITs often provide safety and efficacy evidence that shows whether larger, more expensive clinical studies are worth pursuing, says Dai Jialing, president of PharmaDJ, a Shanghai-based company which provides business intelligence on the biopharmaceutical industry.
Rules governing these trials already existed, but these weren’t strictly enforced or overseen, say researchers. For instance, previous rules required IITs for stem-cell therapies to be conducted at sanjia — China’s top research and training hospitals. However, Iris Zhang, a lawyer at Han Kun Law Offices in Shanghai, says that a good deal of cell-therapy activity took place in non-sanjia institutions, private clinics and hospital-affiliated ventures because supervision at those sites was inconsistent.
This led to a grey market in which companies and hospitals sometimes charged large sums of money for unauthorized or fraudulent therapies. In some cases, this led to medical accidents and even deaths.
What are the new rules?
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