Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome.
Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome.
复制标题
以事件发生时间为结果时，在完全随机因子设计中测试主要效应和相互作用的样本量要求和研究持续时间。
DOI：
10.1080/03610926.2012.705940
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
Halabi,Susan
中科院分区：
文献类型：
--
作者：
Moser,BarryKurt;Halabi,Susan
In this paper, we develop the methodology for designing clinical trials with any factorial arrangement when the primary outcome is time to event. We provide a matrix formulation for calculating the sample size and study duration necessary to test any effect with a prespecified type I error rate and power. Assuming that a time to event follows an exponential distribution, we describe the relationships between the effect size, the power, and the sample size. We present examples for illustration purposes. We provide a simulation study to verify the numerical calculations of the expected number of events and the duration of the trial. The change in the power produced by a reduced number of observations or by accruing no patients to certain factorial combinations is also described.
