有哪些信誉好的足球投注网站a practical simulation method to calculate sample size of group sequential trials for time-to-event data under exponential and weibull distribution实际模拟方法计算样本量集团在指数和威布尔分布序贯试验比较数据.pdfVIP
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a practical simulation method to calculate sample size of group sequential trials for time-to-event data under exponential and weibull distribution实际模拟方法计算样本量集团在指数和威布尔分布序贯试验比较数据
A Practical Simulation Method to Calculate Sample Size
of Group Sequential Trials for Time-to-Event Data under
Exponential and Weibull Distribution
1 1 1 1 2
Zhiwei Jiang , Ling Wang , Chanjuan Li *, Jielai Xia *, Hongxia Jia
1 Department of Health Statistics and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Preventative
Medicine, Fourth Military Medical University, Xi’an, Shaanxi, China, 2 Department of Endocrinology, Jinan General Hospital, Jinan, Shandong, China
Abstract
Group sequential design has been widely applied in clinical trials in the past few decades. The sample size estimation is a
vital concern of sponsors and investigators. Especially in the survival group sequential trials, it is a thorny question because
of its ambiguous distributional form, censored data and different definition of information time. A practical and easy-to-use
simulation-based method is proposed for multi-stage two-arm survival group sequential design in the article and its SAS
program is available. Besides the exponential distribution, which is usually assumed for survival data, the Weibull
distribution is considered here. The incorporation of the probability of discontinuation in the simulation leads to the more
accurate estimate. The assessment indexes calculated in the simulation are helpful to the determination of number and
timing of the interim analysis. The use of the method in the survival group sequential trials is illustrated and the effects of
the varied shape parameter on the sample size under the Weibull distribution are explored by employing an example.
According to the simulation results, a method to estimate the shape parameter of the Weibull distribution is p
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