Study duration for group sequential clinical trials with censored survival data adjusting for stratification.
Study duration for group sequential clinical trials with censored survival data adjusting for stratification.
复制标题
组序贯临床试验的研究持续时间，并根据分层调整删失生存数据。
DOI：
10.1002/sim.4780111106
复制
发表时间：
1992
影响因子：
2
通讯作者：
Kim,K
中科院分区：
文献类型：
--
作者：
Kim,K
在具有删失生存数据的临床试验中，研究持续时间是累积持续时间和随访持续时间之和，累积持续时间决定了传统意义上的样本量，随访持续时间或多或少控制了待观察事件的数量。我们提出了一个设计程序，用于确定研究持续时间或计算功效，在一个组序贯临床试验中，删失生存数据和治疗之间可能不平等的患者分配，调整分层随机化。组序贯方法是基于使用功能方法。我们描述了一个临床试验，最近启动的东部肿瘤协作组的说明拟议的程序。
The study duration in a clinical trial with censored survival data is the sum of the accrual duration, which determines the sample size in a traditional sense, and the follow‐up duration, which more or less controls the number of events to be observed. We propose a design procedure for determining the study duration or for calculating the power in a group sequential clinical trial with censored survival data and possibly unequal patient allocation between treatments, adjusting for stratified randomization. The group sequential method is based on the use function approach. We describe a clinical trial recently activated by the Eastern Cooperative Oncology Group for an illustration of the proposed procedure.