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Volume 14 Issue 1
Jan.  2023
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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
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Interpretation of Guidance for the Design and Implementation of Drug Clinical Studies: Based on E8 (R1): General Considerations for Clinical Trials

  • Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

Funds: 

National High Level Hospital Clinical Research Funding 2022-PUMCH-C-018

National High Level Hospital Clinical Research Funding 2022-PUMCH-A-074

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  • Corresponding author:

    YANG Hong, E-mail: yangh@pumch.cn

  • Received Date: October 22, 2022
  • Accepted Date: December 01, 2022
  • Available Online: December 12, 2022
  • Issue Publish Date: January 29, 2023
    Graphical Abstract
    • 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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    • References (14)
  • [1]
    国家药品监督管理局. 2017年度药品审评报告[EB/OL]. (2018-03-22)[2022-10-20]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20180322103801253.html.
    [2]
    国家药品监督管理局. 2018年度药品审评报告[EB/OL]. (2019-07-01)[2022-10-20]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20190701175802136.html.
    [3]
    国家药品监督管理局. 国家药监局关于适用《E8(R1): 临床研究的一般考虑》和《E14: 非抗心律失常药物致QT/QTc间期延长及潜在致心律失常作用的临床评价》国际人用药品注册技术协调会指导原则的公告(2022年第61号)[EB/OL]. (2022-08-12)[2022-10-20]. https://www.nmpa.gov.cn/directory/web/nmpa/yaopin/ypggtg/20220812151143165.html.
    [4]
    国家药品监督管理局药品审评中心. 溃疡性结肠炎治疗药物临床试验技术指导原则[EB/OL]. (2021-12-27)[2022-10-20]. https://www.cde.org.cn/main/news/viewInfoCommon/c080c9172c57a118746020aa7e2d96d5.
    [5]
    Sharp D, Ringer S, Park KT, et al. Listening to the Patient: Improving the Design and Conduct of Clinical Trials in Inflammatory Bowel Diseases[J]. Crohns Colitis, 2020, 2: 1-4.
    [6]
    国家药品监督管理局药品审评中心. 患者报告结局在药物临床实验中应用的指导原则(试行)[EB/OL]. (2021-12-27)[2022-10-20]. https://www.cde.org.cn/main/news/viewInfoCommon/c2f79c22e8678241b030c71523eb300c.
    [7]
    国家药品监督管理局药品审评中心. 组织患者参与药物研发的一般考虑指导原则(试行)[EB/OL]. (2022-11-21)[2022-10-20]. https://www.cde.org.cn/main/news/viewInfoCommon/41c7a683e4d0dcca28bccadc47096d2a.
    [8]
    国家药品监督管理局药品审评中心. 以患者为中心的临床试验设计技术指导原则(征求意见稿)[EB/OL]. (2022-08-09)[2022-10-20]. https://www.cde.org.cn/main/news/viewInfoCommon/0cccaa1f5aeb73dcebf7d4d3e3e88b1c.
    [9]
    国家药品监督管理局药品审评中心. 以患者为中心的临床试验获益-风险评估技术指导原则(征求意见稿)[EB/OL]. (2022-08-09)[2022-10-20]. https://www.cde.org.cn/main/news/viewInfoCommon/fc162e0cda62ebf42754ee90a98035dd.
    [10]
    国家药品监督管理局药品审评中心. 以患者为中心的临床试验实施技术指导原则(征求意见稿)[EB/OL]. (2022-08-09)[2022-10-20]. https://www.cde.org.cn/main/news/viewInfoCommon/fc162e0cda62ebf42754ee90a98035dd.
    [11]
    国家药品监督管理局药品审评中心. 药物临床试验的一般考虑[EB/OL]. (2017-01-18)[2022-10-20]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=b32eaabf2c4cc56570c23c19f9608076.
    [12]
    Dubinsky MC, Collins R, Abreu MT, et al. Challenges and Opportunities in IBD Clinical Trial Design[J]. Gastroenterology, 2021, 161: 400-404.
    [13]
    Abreu MT. Combining Biologic Agents in Inflammatory Bowel Disease[J]. Gastroenterol Hepatol(NY), 2019, 15: 549-551.
    [14]
    ICH. ICH E10 Choice of Control Group in Clinical Trials[EB/OL]. (2020-07-20)[2022-10-20]. https://www.ich.org/page/efficacy-guidelines.
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