| 非劣效性临床试验中两组率差值的协变量调整方法 |
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| 引用本文： | 侯艳,李康.非劣效性临床试验中两组率差值的协变量调整方法[J].中国卫生统计,2012,29(2):196-198,201. |
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| 作者姓名： | 侯艳 李康 |
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| 作者单位： | 哈尔滨医科大学卫生统计学教研室,150081 |
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| 基金项目： | 国家自然科学基金青年基金资助(81102201) |
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| 摘 要： | 目的 解决新药非劣效性临床试验评价中两组率差值的协变量调整问题.方法 利用ROC曲线与两组率差值的对应关系,通过ROC分析间接得到调整协变量之后两组率之差的估计值及标准误.结果 给出了一种新的非参数分层分析方法,如果协变量对有效率有影响,可以通过调整分析得到更准确的检验结果.结论 本文提供的方法能够更直观、有效地对新药临床试验的数据进行非劣效性评价.
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| 关 键 词： | 临床试验 非劣效性试验 非参数方法 ROC曲线 调整分析 |
Covariate Adjustment for Rate Difference in the Non-inferiority Clinical Trials |
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| Hou Yan
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Li Kang.Covariate Adjustment for Rate Difference in the Non-inferiority Clinical Trials[J].Chinese Journal of Health Statistics,2012,29(2):196-198,201. |
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| Authors: | Hou Yan Li Kang |
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| Institution: | .Department of Biostatistics,Harbin Medical University(150001),Harbin |
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| Abstract: | Objective To address the covariate adjustment for rate difference in non-inferiority clinical trials. MethodsThe relationship between rate difference and ROC curve was used to indirectly obtain the estimator for rate difference and its standardized error. Results We present a novel non-parametric stratified analysis method. ConclusionThis method can visually and effectively assesses the non-inferiority of clinical trials. |
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| Keywords: | Clinical trials Non-inferiority trials Non-parametric method ROC curve |
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