柏小寅, 杨红. 药物临床研究设计及实施规范解读——基于《E8(R1): 临床研究的一般考虑》[J]. 协和医学杂志, 2023, 14(1): 81-85. DOI: 10.12290/xhyxzz.2022-0611
引用本文: 柏小寅, 杨红. 药物临床研究设计及实施规范解读——基于《E8(R1): 临床研究的一般考虑》[J]. 协和医学杂志, 2023, 14(1): 81-85. DOI: 10.12290/xhyxzz.2022-0611
BAI Xiaoyin, YANG Hong. Interpretation of Guidance for the Design and Implementation of Drug Clinical Studies: Based on E8 (R1): General Considerations for Clinical Trials[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 81-85. DOI: 10.12290/xhyxzz.2022-0611
Citation: BAI Xiaoyin, YANG Hong. Interpretation of Guidance for the Design and Implementation of Drug Clinical Studies: Based on E8 (R1): General Considerations for Clinical Trials[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 81-85. DOI: 10.12290/xhyxzz.2022-0611

药物临床研究设计及实施规范解读——基于《E8(R1): 临床研究的一般考虑》

Interpretation of Guidance for the Design and Implementation of Drug Clinical Studies: Based on E8 (R1): General Considerations for Clinical Trials

  • 摘要: 随着我国药物研发和临床研究水平的不断提高,所涉及的药物临床试验范围不断扩大,临床研究设计和实施规范的重要性亦逐渐受到重视。2021年10月,国际人用药品注册技术协调会对原有药物临床研究指导原则进行了首次修订,即《E8(R1):临床研究的一般考虑》,我国国家药品监督管理局近期决定将于2023年7月起使用该原则指导药物临床试验。本文主要从临床工作者的角度对该指导原则的修订背景和重要内容进行解读,并结合我国现有的药物临床研究指导原则实施情况进行分析和讨论,旨在为更好地进行药物临床研究设计与实施提供参考。

     

    Abstract: As clinical research and drug development in China continue to advance, greater attention has been paid to the value of clinical research guidelines. The first revision of the original E8 recommendations (R1), "General Considerations for Clinical Research" was made by the International Council for Harmonization in October 2021. Our National Medical Products Administration has recently opted to implement the rules beginning from July 2023. In order to provide useful references for improved design and execution of drug clinical studies in China, this paper primarily interprets the fundamental background and revision of E8 (R1) from the perspective of clinical workers. It also analyzes and discusses the application of the current clinical study guidelines in China.

     

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