| 随机对照药物临床试验样本量估计 |
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| 引用本文： | 李婵娟,蒋志伟,王锐,夏结来. 随机对照药物临床试验样本量估计[J]. 中国临床药理学与治疗学, 2011, 16(10): 1132-1136 |
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| 作者姓名： | 李婵娟 蒋志伟 王锐 夏结来 |
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| 作者单位： | 第四军医大学卫生统计学教研室,西安710032,陕西 |
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| 基金项目： | 国家自然科学基金资助项目(81001290,非随机对照临床试验选择性偏倚控制方法研究) |
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| 摘 要： | 如何正确估计样本量是随机对照药物临床试验设计阶段的主要研究内容之一。本文在对随机对照临床试验样本量估计的影响因素一一分析的基础上,通过实例介绍临床试验样本量估计的分析过程,并讨论了临床试验样本量估计中的注意事项,为随机对照临床试验正确估计样本量提供参考。
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| 关 键 词： | 临床试验 样本量估计 检验效能 |
Sample size estimation in randomized controlled drug clinical trials |
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| LI Chan-juan,JIANG Zhi-wei,WANG Rui,XIA Jie-lai. Sample size estimation in randomized controlled drug clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2011, 16(10): 1132-1136 |
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| Authors: | LI Chan-juan JIANG Zhi-wei WANG Rui XIA Jie-lai |
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| Affiliation: | LI Chan-juan,JIANG Zhi-wei,WANG Rui,XIA Jie-lai Department of Health Statistics,Fourth Military Medical University,Xi'an 710032,Shaanxi,China |
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| Abstract: | Sample size estimation is a key research aspect in randomized controlled drug clinical trial.Sample size estimation factors,parameters and basic rules are discussed in our research.In addition,sample size estimation procedures are introduced based on two examples.A reference is provided for estimating sample size in randomized controlled clinical trials. |
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| Keywords: | Clinical trials Sample size estimation Test power |
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