| 引用本文: | 阮未艾,姚峥嵘,王艳翚,张彧.拓展性临床试验制度的中国实践及探索——以同情用药为视角[J].中国现代应用药学,2021,38(18):2273-2277. |
| RUAN Wei'ai,YAO Zhengrong,WANG Yanhui,ZHANG Yu.Practice and Exploration of Extended Clinical Trial System in China: From the Perspective of Compassionate Use System[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(18):2273-2277. |
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| 摘要: |
| 目的 为中国拓展性临床试验发展完善提供思路。方法 通过文献研究等方法对国内外拓展性临床试验的发展、中国实践中的难题进行研究。结果 中国拓展性临床试验在风险评估方面存在争议、申请发起人尚未确定、申请审批时长有待缩短。结论 结合中国具体国情，从明确责任归属、分摊风险和搭建审查体系3个方面进行拓展性临床试验的完善。 |
| 关键词: 拓展性同情用药制度 临床试验 特别审批 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.18.013 |
| 分类号:R95 |
| 基金项目:教育部人文社会科学研究规划基金项目（16YJA820022）；江苏省科协调研课题（JSKXKT2021023） |
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| Practice and Exploration of Extended Clinical Trial System in China: From the Perspective of Compassionate Use System |
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RUAN Wei'ai, YAO Zhengrong, WANG Yanhui, ZHANG Yu
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School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing 210023, China
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| 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. |
| Key words: extended sympathetic drug system clinical trial special approval |
