Excerpted from BMJ, Liming Lu, Yuqing Zhang, Gordon Guyatt, Chunzhi Tang, Nenggui Xu write:
China has the potential to become one of the world’s most favoured sites for performing clinical trials.[1] Since 2008,[1] although China has seen a decline in the growth rate of clinical trials, it still stands as one of the regions with the highest growth rate worldwide.[2] A number of factors make China extremely attractive as a site for large, high quality clinical trials. With 20% of the world’s population, and a pattern of morbidity and mortality that is increasingly similar to Western countries, China’s potential to recruit a sufficient number of participants to conduct large studies is enormous.
Nevertheless, China’s clinical trial experience is still in its infancy and faces serious challenges. China’s major challenges include a slow trial registration process; lack of training in medical school, hospitals, and institutions; and a scarcity of experience in leading or participating in high quality trials. China has one of the slowest trial examination and approval processes in the world. The average time delay for an application to register a clinical trial of an innovative drug was 14 months, which is 10 times longer than the United States.[2][5] Ineffective communication, poor coordination among multiple regulatory authorities and drug inspection departments, and a lack of trained staff are in part responsible for the glacial pace of approval.
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