Lakatos E
Biostatistics Research Branch, National Heart, Lung, and Blood Institute, Bethesda, Maryland 20892.
Biometrics. 1988 Mar;44(1):229-41.
The log-rank test is frequently used to compare survival curves. While sample size estimation for comparison of binomial proportions has been adapted to typical clinical trial conditions such as noncompliance, lag time, and staggered entry, the estimation of sample size when the log-rank statistic is to be used has not been generalized to these types of clinical trial conditions. This paper presents a method of estimating sample sizes for the comparison of survival curves by the log-rank statistic in the presence of unrestricted rates of noncompliance, lag time, and so forth. The method applies to stratified trials in which the above conditions may vary across the different strata, and does not assume proportional hazards. Power and duration, as well as sample sizes, can be estimated. The method also produces estimates for binomial proportions and the Tarone-Ware class of statistics.
对数秩检验常用于比较生存曲线。虽然二项比例比较的样本量估计已适用于诸如不依从、延迟时间和交错入组等典型临床试验条件，但在使用对数秩统计量时的样本量估计尚未推广到这类临床试验条件。本文提出了一种在存在无限制的不依从率、延迟时间等情况下，通过对数秩统计量估计生存曲线比较样本量的方法。该方法适用于分层试验，其中上述条件在不同层可能有所不同，且不假定风险比例。可以估计检验效能、持续时间以及样本量。该方法还能对二项比例和Tarone-Ware统计量类别进行估计。
