A Practical Simulation-Based Method to Calculate Sample Size of Group Sequential Trials for Time-to-Event Data under Exponential and Weibull Distributions

摘要：

Group sequential design has been widely applied in clinical trials in the past few decades and the sample size estimation is a vital concern of sponsors and investigators. However, it is a thorny question to survival group sequential trials because of its ambiguous distributional forms, censored data and different definition of information time. And the theoretical approaches seem too complicated to be applied in actual trials. The simulation-based method is a good choice to calculate the sample size due to its simplicity and flexibility.

关键词： Time-to-event data Group sequential design Sample size estimation Exponential distribution Weibull distribution Monte Carlo simulation

作者: Zhiwei Jiang Ling Wang Chanjuan Li Jielai Xia

作者单位: Department of Health Statistics,School of Preventative Medicine,Fourth Military Medical University,N Department of Health Statistics, School of Preventative Medicine,Fourth Military Medical University, Department of Health Statistics,School of Preventative Medicine,Fourth Military Medical University,N

会议类型: 国际会议

会议名称: Second Joint Biostatistics Symposium(第二届生物统计国际研讨会2012)

会议地点: 北京

会议语种:英文

页码: 480-505

在线出版日期: 2012-07-08（万方平台首次上网日期，不代表论文的发表时间）