Abstract: OBJECTIVE To provide ideas for the improvement of extended clinical trial in China. METHODS The development of extensive clinical trials at home and abroad and the practical problems in China were studied by means of literature research. RESULTS China's expanded clinical trials were controversial in terms of risk assessment, application sponsors had not yet been identified, and the length of application approval needed to be shortened. CONCLUSION According to the specific national conditions of China, the improvement of the extended clinical trial should be carried out from three aspects:clear accountability, risk allocation and establishment of review system.