临床试验的适应性设计  

Adaptive designs for clinical trial

作　　者：李卫[1] 贺善菊[2] 王杨[1] 成小如[1] 贾宣[1] 

机构地区：[1]中国医学科学院阜外心血管病医院卫生部心血管病防治研究中心生物统计部,北京100037 [2]北京师范大学数学科学学院

出　　处：《中华流行病学杂志》2007年第6期605-607,共3页Chinese Journal of Epidemiology

摘　　要：目的介绍临床试验适应性设计概念和具体使用方法，使读者对临床试验适应性设计有一个初步的认识。方法通过实例介绍临床试验适应性设计的基本思想和概念。结果阐述临床试验适应性设计与成组序贯方法间的异同点，同时介绍在适应性设计中，如何体现临床试验的两个基本的统计学原则。结论适应性方法给临床试验设计带来了很大的灵活性，可以更大程度地提高研究工作的效率。Objective In order to provide readers with general concepts and methodology on adaptive designs for clinical trial. Methods Definition of adaptive designs for clinical trial and basic idea of adaptive adjustment were introduced through an example. Results The relationship between adaptive designs and group sequential design was summarized. Ways to embody two basic statistical rules of clinical trial under adaptive adjustments setting were also introduced. Conclusion Adaptive designs provided clinical trial with a great flexibility, which could greatly improve the efficiency of clinical trial.

关 键 词：临床试验 适应性设计 成组序贯法 中期分析 

分 类 号：R686[医药卫生—骨科学]