| 临床试验中多终点期中分析方法研究 |
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| 引用本文： | 郭静,金水高,徐勇勇. 临床试验中多终点期中分析方法研究[J]. 现代预防医学, 2007, 34(5): 870-872 |
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| 作者姓名： | 郭静 金水高 徐勇勇 |
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| 作者单位： | 1. 中国疾病预防控制中心公共卫生监测与信息服务中心卫生统计研究室,北京,100050
2. 第四军医大学卫生统计学教研室 |
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| 摘 要： | [目的]介绍临床试验中多终点期中分析方法。[方法]在多终点分析的基础上将单变量成组序贯期中分析方法进一步扩展,介绍多终点(变量)期中分析方法。[结果]多终点期中分析方法可以分为2大类,分别对每个终点进行单变量分析,同时对每个终点的检验界值进行校正;或利用所有观察终点构造总的检验统计量进行分析。[结论]确定单变量成组序贯期中分析界值的方法可以扩展用于多终点期中分析。
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| 关 键 词： | 临床试验 多终点 期中分析 检验界值 |
| 文章编号： | 1003-8507（2007）05-0870-03 |
| 收稿时间： | 2006-05-15 |
| 修稿时间： | 2006-05-15 |
THE STUDY OF MULTIPLE ENDPOINTS INTERIM ANALYSIS IN CLINICAL TRIALS |
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| GUO Jing,JIN Shui-gao,XU Yong-yong. THE STUDY OF MULTIPLE ENDPOINTS INTERIM ANALYSIS IN CLINICAL TRIALS[J]. Modern Preventive Medicine, 2007, 34(5): 870-872 |
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| Authors: | GUO Jing JIN Shui-gao XU Yong-yong |
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| Affiliation: | Department of Health Statistics. The Chinese Center of Disease Control and Prevention. Beijing 100050, China |
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| Abstract: | [Objective]To introduce the multiple endpoints interim analysis methods in clinical trials.[Methods]Based on multiple endpoints analysis methods,the group sequential interim analysis methods for single variable were extened to multi endpoints interim analysis.[Results]Multiple endpoints interim analysis methods could be divided into two kinds:analysis each endpoint with modification to its test boundary;or test the global statistics constructed from all endpoints.[Conclusion]The boundary calculation method for group sequential interim analysis of single variable can be extended to multiple endpoints interim analysis. |
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| Keywords: | Clinical trials Multiple endpoints Interim analysis Boundary |
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