南方医科大学学报 ›› 2015, Vol. 35 ›› Issue (11): 1638-.

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贝叶斯期中分析与经典期中分析在成组序贯设计中的比较

原玲玲,詹志颖,谭旭辉   

  • 出版日期:2015-11-20 发布日期:2015-11-20

Comparison of Bayesian interim analysis and classical interim analysis in group
sequential design

  • Online:2015-11-20 Published:2015-11-20

摘要: 目的比较贝叶斯期中分析与经典方法的期中分析的差异。方法以对照组(Control)和试验组(Treatment)的两样本均数
比较为分析目的,即θ = μT - μC(θ越大疗效越好),建立H0:θ ≤0;H1:θ > 0的优效性假设检验(拒绝H0,即支持处理组疗效)。按照成
组序贯设计的数据要求,在每次期中分析时刻,计算各种先验分布的贝叶斯期中分析Ⅰ类错误、功效、平均样本量、平均阶段数
等指标。结果在Pocock 和O’Brien & Fleming 设计中,Skeptical 先验和Handicap 先验的Ⅰ类错误ε均能控制在0.05 左右。当
O’ Brien & Fleming和Pocock方法功效在80%时,基于Handicap先验和Skeptical先验的贝叶斯功效相对来说明显较低,而基于
Non-informative先验和Enthusiastic先验的贝叶斯功效则明显较高。结论Skeptical先验和Handicap先验的贝叶斯期中分析能
较好的控制Ⅰ类错误ε,基于Skeptical先验和Handicap先验的贝叶斯期中分析相对于O’Brien & Fleming方法均能够明显增加
试验提前终止的可能性,而对于Pocock方法则没有太大实际意义。

Abstract: Objective To explore the differences between the Bayesian interim analysis and the classical interim analysis.
Methods To compare the means of two independent samples between control and treatment, superior hypothesis test was
established. In line with the data requirements for group sequential design, Type I error of Bayesian interim analysis based on
various prior distributions, Power, Average Sample Size and Average Stage were estimated in the interim analysis. Results In
the Pocock and O’ Brien & Fleming designs, the Type I errors in the Bayesian interim analysis based on the skeptical prior
distribution and the handicap prior distribution were controlled at around 0.05. When the powers of these two classical
designs were both 80%, Bayesian powers of the skeptical prior distribution and the handicap prior distribution were markedly
lower. The powers of the non-informative prior distribution and the enthusiastic prior distribution were distinctly higher than
80%. Conclusion In the Bayesian interim analysis based on the skeptical prior distribution and the handicap Prior distribution,
the Type I errors can be well controlled. Bayesian interim analyses using these two prior distributions, compared with the
analysis adopting the O’ Brien & Fleming method, can markedly increase the possibility of ending the clinical trials ahead of
time. The Bayesian interim analyses based on these two distributions do not have practical value for group sequential design
of the Pocock method.