以"复发事件"为观察结局的临床试验常用有效性评价指标的比较

目的正确选择以“复发事件”为观察结局的临床试验有效性评价指标。方法从统计学角度,对这类临床试验的有效性评价指标构建方法进行分析和比较,并结合实例进一步进行说明。结果根据Cox风险率函数构建的风险比(HR)指标比较适合应用于该类资料的疗效评价,而其他几个指标都存在一些问题。结论在选取“复发事件”为观察结局的临床试验有效性评价指标时一定要注意其应用条件及数据收集的情况,必要时需要几种方法一同应用以验证结果。建议采用根据Cox风险率函数为该类临床试验有效性评价指标,并计算组间比较的风险比。

The Comparison of The efficarcy Assessment Indexes from Recurrent Event Data

Objective To discuss the selection of the commonly used efficacy assessment indexes that is used to deal with recurrent event data.Methods To compare the conformational methods of these indexes with the statistics point of view.An example was used in order to have a deeper discussion.Results The HR value constructed by Cox hazard function is more appropriate to this kind data than the other indexes.Because there are some questions in them.Conclusion To take attention to the condition of the data collection and methods to be used.We should use some analysis methods together to check up the results when it is necessary.And the Cox hazard function is suggested to be adopted.