临床试验中中心效应的评价及处理方法

探讨多中心临床试验中, 中心效应的评价与处理方法, 采用Breslow-Day 检验对有效率的中心间差异进行评价, 采用CMH 方法对组间有效率及疗效等级进行分析, 采用logistic 回归方法对中心效应及有效率或疗效等级同时进行评价。结果提示,Breslow-Day 检验只能对有效率的中心间差异进行评价, 而不能对疗效等级的中心差异进行评价, CMH方法不能同时考虑其它协变量的影响。

Statistical approaches for evaluating and dealing with center effects in multi-center clinical trial

To search the statistical approaches for evaluating and dealing with the center effects in multicenter clinical trial. Breslow-Day test was used for evaluating the differences of the virtual rating among the centers whose responses were binary, Cochran-Mantel-Haenszel test for dealing with the center effects whose responses were binary or ordinal, and logistic regression for evaluating and dealing with the center effects simultaneously. The results showed that Breslow-Day test is invalid in evaluating the center effects whose response is ordinal, and Cochran-Mantel-Haenszel test can not be used for dealing with the effects of other covariates meanwhile.