| 临床试验中平行组设计二分类指标样本量的计算 |
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| 引用本文： | 杨立波. 临床试验中平行组设计二分类指标样本量的计算[J]. 中国新药杂志, 2011, 0(24) |
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| 作者姓名： | 杨立波 |
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| 作者单位： | 河北以岭医药研究院生物统计室; |
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| 摘 要： | 临床试验中所需病例数应符合统计学要求,以确保对所提出的问题给予可靠的回答。样本的大小通常以试验的主要指标来确定,同时应考虑试验设计类型、比较类型等。针对优效/非劣效/等效性试验的目的及统计假设检验和方差,文中介绍了二分类指标平行组试验设计样本量的计算方法和通用公式,并结合临床试验的实际案例对样本量计算进行了应用分析。
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| 关 键 词： | 临床试验 二分类指标 样本量 优效性 非劣效性 等效性试验 |
Sample size estimation for binary data in clinical trials with parallel group design |
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| YANG Li-bo. Sample size estimation for binary data in clinical trials with parallel group design[J]. Chinese Journal of New Drugs, 2011, 0(24) |
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| Authors: | YANG Li-bo |
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| Affiliation: | YANG Li-bo(Hebei Liling Medicine Academy,Biostatistics Department,Shijiazhuang 050035,China) |
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| Abstract: | The number of subjects in clinical trials should comply with the statistical requirements to provide a reliable answer to the questions addressed.This number is usually determined by the primary objective of the trial.At the same time experimental design type and comparative type should be considered.Focusing on superiority,non-inferiority,equivalence trials,statistics hypothesis test and variance,this article introduced sample size estimation method and universal formula for parallel group clinical trials ... |
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| Keywords: | clinical trials binary data sample size superiority non-inferiority equivalence trials |
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