| 李卫,贺善菊,王杨,成小如,贾宣.临床试验的适应性设计[J].Chinese journal of Epidemiology,2007,28(6):605-607 |
| 临床试验的适应性设计 |
| Adaptive designs for dinical trial |
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| DOI： |
| KeyWord: 临床试验 适应性设计 成组序贯法 中期分析 |
| English Key Word: Clinical trial Adaptive designS Group sequential design Interim analysis |
| FundProject: |
| Author Name | Affiliation | | LI Wei | National Centre for Cardivascular Disease, Cardivascular Insititute and Fuwai Hospital, Chinese Academy of Medical Sciensices and Peking Union Medical College, Beijing 100037, China | | HE Shan-ju | National Centre for Cardivascular Disease, Cardivascular Insititute and Fuwai Hospital, Chinese Academy of Medical Sciensices and Peking Union Medical College, Beijing 100037, China | | WANG Yang | National Centre for Cardivascular Disease, Cardivascular Insititute and Fuwai Hospital, Chinese Academy of Medical Sciensices and Peking Union Medical College, Beijing 100037, China | | CHENG Xiao-ru | National Centre for Cardivascular Disease, Cardivascular Insititute and Fuwai Hospital, Chinese Academy of Medical Sciensices and Peking Union Medical College, Beijing 100037, China | | JIA Xuan | National Centre for Cardivascular Disease, Cardivascular Insititute and Fuwai Hospital, Chinese Academy of Medical Sciensices and Peking Union Medical College, Beijing 100037, China |
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| Abstract: |
| 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。 |
| English Abstract: |
| Objective In order to pmvide 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 rLlles of clinical trial under ad印tive adjustments setting were also introduced.Conclusion Adaptive designs provided clinical trial with a great nexibility，which could greatly improve the efficiency of clinical trial． |
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