新药临床试验中桥接试验的统计学相关相似性评价方法和桥接策略  

Statistical methods for assessing ethnic similarity and bridging strategy of bridging studies in simultaneous global drug development

作　　者：刘泽宇[1] 周叙华 韩孝先 夏结来[1] 李晨[1] 

机构地区：[1]第四军医大学军事预防医学院,西安710032 [2]杭州师范大学钱江学院,杭州310012

出　　处：《中国新药杂志》2016年第15期1733-1736,共4页Chinese Journal of New Drugs

基　　金：国家自然科学基金资助项目(81273176)

摘　　要：国际同步药物研发中,桥接试验的应用可以节约医疗资源、缩短研发时间。越来越多的研究围绕着不同区域新药临床试验的种族"相似性"、"一致性"的医学统计学相关评价和桥接策略进行了深入探讨。本文对桥接试验的相似性、一致性评价方法和桥接策略相关的统计分析方法作一综述,以期促进桥接试验的应用,减少重复试验,缩短新药审批时间,使有效药物及早上市造福患者。Bridging study can save medical resources and shorten development time in simultaneous global drug development. More and more researches focus on the ＂similarity＂or ＂consistency＂of clinical trials in different ethnic populations these years. In this paper,we reviewed the statistical analysis and evaluation methods for ethnic similarity and bridging strategy in bridging study so as to promote the application of bridging study,decrease the resources for new drug development,and benefit the patients.

关 键 词：国际同步药物研发 桥接试验 种族因素 相似性 

分 类 号：R969[医药卫生—药理学]