[International comparison and assessment of the quality of drug clinical trial implementation in China based on scientific regulatory system].

H Fang, Y R Hou,H Y Huang,D W Wu, S P Jia, Y Tang,N Li

Zhonghua zhong liu za zhi [Chinese journal of oncology](2023)

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摘要
With the rapid development of clinical research and the continuous enhancement of innovation capability in China, the quality of clinical research under China's scientific regulatory system has drawn widespread attention. This study evaluated the quality results of China's drug clinical trials implementation, compared the scientific regulatory systems of clinical research quality between China and the United States, analyzed real-world clinical application on the approval of new anti-tumor drugs through clinical trials, in order to analyze China's status and level of clinical trial implementation quality in the international industry, and explore the advantages and value of China's clinical research scientific regulation by collecting clinical trial data inspections disclosed by regulatory agencies in both China and the United States, as well as verifying information on the approval of new anti-tumor drugs.
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关键词
clinical trial implementation,scientific regulatory system,international comparison
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