Sample size determination for group sequential clinical trials with immediate response.
Sample size determination for group sequential clinical trials with immediate response.
复制标题
立即响应的组序贯临床试验的样本量确定。
DOI：
10.1002/sim.4780111012
复制
发表时间：
1992
影响因子：
2
通讯作者：
Demets,DL
中科院分区：
文献类型：
--
作者：
Kim,K;Demets,DL
使用功能的方法来组序贯方法已被探索以前。任何成组序贯设计都需要指定重复分析的频率和次数，但只有使用函数方法允许偏离设计中指定的频率和次数，而不影响分析中的I类错误。本文阐述了如何使用功能提供了一个简单而灵活的设计程序，以及如何最初预计的最大样本量可以计算随机临床试验中，响应是已知的患者进入后相对较短的时间内，并有一个提前停止规则内置到研究方案。此外，使用建议的设计程序的后果进行调查，在随后的组序贯分析的操作特性。
The use function approach to group sequential methods has been explored previously. Any group sequential design requires specifying the frequency and times of repeated analyses, but only the use function approach allows deviations from those specified in the design, without affecting the type I error in the analysis. This paper illustrates how the use function provides a simple and flexible design procedure and how the initially projected maximum sample size can be calculated for randomized clinical trials in which responses are known relatively soon after patient entry and for which there is an early stopping rule built into the study protocol. Also the consequence of using the proposed design procedure is investigated in terms of the operating characteristics of the subsequent group sequential analyses.