Abstract：OBJECTIVE To provide ideas for the improvement of expanded access trials in China. METHODS By referring to domestic and foreign literatures, this study made a comparative analysis of expanded access trials from three aspects: domestic and foreign development, similarities and differences with special innovative medical device and off-label use. RESULTS Expanded access trials is of great value in the context of the increasingly evolving disease spectrum because of its humanism and treatment needs. However, there are still no practical cases in China and its operating mechanism still needs to be improved. CONCLUSION China should learn from foreign experience, refer to relevant norms of special drug use behavior, strengthen policy guidance, and realize the grafting and application of the system.
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RUAN Wei-ai, YAO Zheng-rong, WANG Yan-hui. Comparative Study of Special Drug Use Behavior Based on Extended Clinical Trials and Its Implications. Chinese Pharmaceutical Journal, 2022, 57(8): 669-674.
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2022, Vol. 57 
