SHANGHAI: Chinese authorities fired two researchers and disciplined several others after an investigation found safety and ethical flaws in an experimental gene-editing study that led to the death of a child.
The two key researchers leading the study at Shanghai Jiao Tong University School of Medicine also were barred for five years from government science and technology projects, state media China Central Television reported on Friday (Nov 13). Several others received penalties, including removal from their posts, demotions and disciplinary warnings, according to the CCTV report that cited a Shanghai investigative task force.
Investigators found scientists failed to flag warning signals from a non-human-primate safety and didn’t disclose the child’s death in a research paper published in February, CCTV said. No data fabrication was found, though other academic irregularities and undisclosed conflicts of interest were identified.
The hospital’s ethics committee approved the study despite insufficient toxicology and safety evidence, and the risk of death wasn’t highlighted in the informed consent disclosures.
Shanghai authorities said they will strengthen oversight of clinical research involving new biomedical technologies, including high-risk cell and gene therapies, according to the report. The city’s health commission has drawn up a special inspection plan and begun inspections and rectification work, it added.
The child’s death, first reported in late July by Science and Retraction Watch, drew scrutiny of China’s booming early-stage clinical trials, particularly those involving cell and gene therapies. Under China’s dual-track regulatory system, doctors at major hospitals can test certain novel therapies after local review, without approval from the national drug regulator.
Such studies, known as investigator-initiated trials, or IITs, have surged in recent years, accelerating the development of cutting-edge drugs that are fueling China’s biotech boom. But the July death - and two others that subsequently came to light in trials of therapies developed by Huidagene Therapeutics and RiboX Therapeutics - raised questions around whether oversight, safety reporting and public disclosure have kept pace with the sector’s rapid growth.
In August, two US lawmakers cited the three deaths when urging the Food and Drug Administration to increase scrutiny of study data originating from China.
The international attention on IITs comes as China rolls out new regulations that took effect in May, limiting trials to top-tier hospitals, imposing stricter manufacturing standards and introducing tougher penalties for non-compliance.
The revamp marks a shift from "wild growth” toward "regulated prosperity,” Xu Anlong, dean of the Sun Yat-sen University Institute of Advanced Study Hong Kong, wrote in a commentary. - Bloomberg
