中国临床药理学与治疗学2011，Vol.16Issue(10)：1126-1131,6.
多中心临床试验疗效一致性评价方法
Consistency efficacy assessment of multi-regional clinical trials
摘要
Abstract
The multi-regional clinical trials (MRCTs) have received wide attention with an increasing trend of globalization of clinical trials. A key issue in MRCTs is how to assess the consistency of treatment effect across regions. In this paper, we provide a systematic review of methods that be commonly used for assessing the consistency in MRCTs. We also give some simple discussion about the choice of methods of assessing the consistency of treatment effect across regions, such as the power of the test, the false-positive rate and the relationship between the type I error and the sample size. Thepurpose of this paper is to provide some reference for the members in designing and conducting MRCTs and offer some theory evidences of clinical trails for new drug development. We hope that more researchers can concern this study in this field, promoting the development of MRCTs in our country.关键词
多中心临床试验/一致性/异质性/定量/定性Key words
Multi-regional clinical trials (MRCTs)/ Consistency/ Heterogeneity/ Quantitative/ Qualitative分类
医药卫生引用本文复制引用
王菲,谢海棠,江波,言方荣..多中心临床试验疗效一致性评价方法[J].中国临床药理学与治疗学,2011,16(10):1126-1131,6.基金项目
国家自然科学基金项目(11171065) （11171065）
