新药临床试验中的桥接试验

中国临床药理学与治疗学 ›› 2008, Vol. 13 ›› Issue (3): 309-314.

新药临床试验中的桥接试验

辛卫权, 荀鹏程, 于浩, 陈峰

南京医科大学流行病与卫生统计学系, 南京210029, 江苏

收稿日期:2007-10-26 修回日期:2007-10-26 发布日期:2020-10-15
通讯作者: 陈峰, 男, 教授, 博导, 研究方向:医学现场研究中的统计理论与方法。Tel:025-86862754 E-mai l:Dr.chenfeng @163.com

Bridging studies in clinical trials for new drug application

XIN Wei-quan, XUN Peng-cheng, YU Hao, CHEN Feng

Department of Epidemiology and Health Statistics, Nanjing Medical University, Nanjing 210029, J iangsu, China

Received:2007-10-26 Revised:2007-10-26 Published:2020-10-15

摘要/Abstract

摘要： 目的介绍新药临床试验中桥接试验的概念和实施策略。方法本文介绍了ICH E5 中提出的桥接试验的概念和亚洲桥接试验的现况, 结合实例介绍了桥接策略的具体实施。结果随着ICH E5 的发布以及桥接试验在一些国家和地区的成功实施, 桥接试验已经成为新药注册申请的一个重要形式。结论桥接试验对于外推国外的临床试验数据, 判断药品种族差异, 减少重复试验, 缩短新药审批时间将有重要的意义。

关键词: 桥接试验, 桥接策略, 桥接试验评估, 种族因素, 外推性, 相似性

Abstract: AIM: To introduce the concept of bridging study and its strategies in clinical trials for new drug application. METHODS: The concept of bridging study proposed in the ICH E5 guideline was introduced, with a case using bridging strategies in the new drug applications (NDAs) approved by the regulatory authority in Japan.The concrete mode and the development of bridging studies in Asia were summarized. RESULTS: With the application of the ICH E5, some countries and regions have successfully used the bridging strategy in the new drug applications.The bridging strategy is becoming a common and practical basis for the decision making of marketing approvals of new drugs in the Asia-pacific country. CONCLUSION: The currently bridging studies in Asia will play an important role in the extrapolation of foreign clinical data in new drug application.Using bridging study is very helpful in judging ethnic differences of drugs, reducing duplication of clinical trails, as well as shortening clinical development periods.

Key words: bridging study, bridging strategy, bridging justification, ethnic factor, extrapolation, similarity

中图分类号:

R969

辛卫权, 荀鹏程, 于浩, 陈峰. 新药临床试验中的桥接试验[J]. 中国临床药理学与治疗学, 2008, 13(3): 309-314.

XIN Wei-quan, XUN Peng-cheng, YU Hao, CHEN Feng. Bridging studies in clinical trials for new drug application[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(3): 309-314.

参考文献

[1] ICH.International Conference on Harmonization Tripatite Guidence E5.Ethnic factors in the acceptability of foreign clinical data[C].The U.S.Fed Reg, 1998, 83:31790-31796.
[2] 桑国卫. 新药临床研究中的“ 桥接” 试验[J].中国处方药, 2003, 2(2):50-53.
[3] Naito, Chikayuki.Ethnic factors in the acceptability of foreign clinical data[J].Drug Inf J, 1998,32:1283-1292.
[4] Liu JP, Chow SC.Bridging studies in clinical trails[J].J Biopharm Stat, 2002, 12(3):231-239.
[5] Uyama Y, Shibata T, Nagai N, et al.Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan[J].Clin Pharmacol Ther, 2005, 78(2):102-113.
[6] Takeyuki S.The current status of clinical trails in Japan[J].Drug Inf J, 2003,37:183-188.
[7] Tanaka M, Nagata T.Characterization of clinical data packages using foreign data in new drug applications in Japan[J].Clin Pharmacol Ther, 2007, 5, Sep.[Epub ahead of print]
[8] Rumiko S, Yuki A, Shinji H.Development of triptans in Japan:bridging strategy based on the ICH-E5 guideline[J].J Health Sci, 2006, 52(4):443-449.
[9] Sakai F, Iwata M, Tashiro K, et al.Zolmitriptan is effective and well torelated in Japanese patients with migraine:a dose-reponse study[J].Cephalalgia, 2002, 22(5):376-383.
[10] Stephen D.The bridging justification.APEC workshop on bridging study.Tokyo University[EB OL].http: www. pharm.kitasato-u.ac.jp biostatis presentation2002 Session3.
[11] Shao J, Chow SC.Reproducibility probability in clinical trials[J].Stat Med, 2002, 21(12):1727-1742.
[12] Chow SC, Shao J, Hu OY.Assessing sensitivity and similarity in bridging studies[J].J Biopharm Stat, 2002, 12(3):385-400.
[13] Mizuno S, Yamaguchi T, Fukushima A, et al.Overlap coefficient for assessing the similarity of pharmacokinetic data between ethnically different populations[J].Clin Trials, 2005, 2(2):174-181.
[14] Scott DP, Byron J.Pharmacokinetic bridging and ICH-E5: Retrospective and simulation assessment of proposals for pharmacokinetic equivalence assessment between independent populations[J].Biom Sci Tech Poli Doc, 2002, 4, Dec.
[15] Liu JP.Sample size requirements for evaluation of bridging evidence[J].Biom J, 2002, 44(8):969-981.
[16] Shih WJ.Clinical trials for drug registrations in Asian Pacific countries:Proposal for a new paradigm from a statistical perspective[J].Contr Clin Trials, 2001, 22(4):357-366.
[17] Liu JP, Hsiao CF, Hsueh H.Bayesian approach to evaluation of bridging studies[J].J Biopharm Stat, 2002, 12(3):401-408.
[18] Liu JP, Hsueh.H, Hsiao CF.A Bayesian noninferiority approach to evaluation of bridging studies[J].J Biopharm Stat, 2004, 14(2):291-300.
[19] Hsiao CF, Xu JSh, Liu JP.A group sequential approach to evaluation of bridging studies[J].J Biopharm Stat, 2003, 13(4):793-801.
[20] Lan KK, Soo Y, Siu C, et al.The use of weighted Z-tests in medical research[J].J Biopharm Stat, 2005, 15(4): 625-639.