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.
-
Key words:
- drug research and development /
- clinical research /
- guideline /
- study design /
- interpretation
作者贡献:柏小寅负责文献查阅、资料收集及论文撰写;杨红负责组织选题和论文审校。利益冲突:所有作者均声明不存在利益冲突 -
[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.
点击查看大图
计量
- 文章访问数: 1976
- HTML全文浏览量: 501
- PDF下载量: 66
- 被引次数: 0