| 多终点变量对药物疗效评价的影响 |
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| 引用本文： | 王陵,蒋志伟,李婵娟,王永吉,夏结来.多终点变量对药物疗效评价的影响[J].中国新药杂志,2011(24). |
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| 作者姓名： | 王陵 蒋志伟 李婵娟 王永吉 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;解放军第309医院医务部; |
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| 基金项目： | 国家自然科学基金(81072390) |
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| 摘 要： | 目的:探讨在新药临床试验中多终点变量对药物疗效评价的影响。方法:通过Monte Carlo模拟探索在不同疗效分布类型中多终点变量间的相关性及其对疗效客观评价的影响,并比较不同校正方法控制试验总的Ⅰ类错误的优劣。结果:在不同疗效分布类型中多终点变量间存在不同程度的相关性,在控制整个试验的alpha消耗中若考虑到多终点变量间相关性的存在,较之于一般的校正法能更好地控制试验总的Ⅰ类错误。结论:在新药临床试验中应严格控制主要指标个数,可根据疗效分布类型选择合适的评价指标,当存在多个主要指标时应考虑到指标间的相关性,并采用合适的校正方法控制试验的假阳性率。
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| 关 键 词： | 临床试验 多终点 Ⅰ类错误 alpha消耗 Monte Carlo模拟 |
Effect of multiple endpoints on the efficacy assessment in clinical trials |
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| WANG Ling,JIANG Zhi-wei,LI Chan-juan,WANG Yong-ji,XIA Jie-lai.Effect of multiple endpoints on the efficacy assessment in clinical trials[J].Chinese Journal of New Drugs,2011(24). |
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| Authors: | WANG Ling JIANG Zhi-wei LI Chan-juan WANG Yong-ji XIA Jie-lai |
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| Institution: | WANG Ling1,JIANG Zhi-wei1,LI Chan-juan1,WANG Yong-ji2,XIA Jie-lai1(1 Department of Health Statistics,Faculty of Preventative Medicine,The Fourth Military Medical University,Xi'an 710032,China,2 Department of Medical Administration,The 309th Hospital of Chinese People's Liberation Army,Beijing 100094,China) |
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| Abstract: | Objective: To determine the effect of multiple endpoints on efficacy assessment in clinical trials.Methods: By Monte Carlo simulation,we studied the correlations of multiple endpoints in different efficacy distributions and corresponding effect on the efficacy assessment in clinical trials,and compared the performances of several adjusted methods on controlling the Family-Wise type I error rate(FWER).Results: Simulation results showed that different degrees of correlations existed between different multiple... |
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| Keywords: | clinical trial multiple endpoints type I error alpha spending Monte Carlo simulation |
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