Thall P F, Sung H G
Department of Biomathematics, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
Stat Med. 1998 Jul 30;17(14):1563-80. doi: 10.1002/(sici)1097-0258(19980730)17:14<1563::aid-sim873>3.0.co;2-l.
We present some practical extensions and applications of a strategy proposed by Thall, Simon and Estey for designing and monitoring single-arm clinical trials with multiple outcomes. We show by application how the strategy may be applied to construct designs for phase IIA activity trials and phase II equivalence trials. We also show how it may be extended to incorporate the use of mixture priors in settings where a Dirichlet distribution does not adequately quantify prior experience, randomized phase II selection trials involving two or more experimental treatments, and trials with group-sequential monitoring for applications involving multiple institutions.
我们展示了由索尔、西蒙和埃斯蒂提出的一种策略的一些实际扩展和应用,该策略用于设计和监测具有多个结果的单臂临床试验。通过应用,我们展示了该策略如何应用于构建IIA期活性试验和II期等效性试验的设计。我们还展示了它如何扩展,以纳入在狄利克雷分布不能充分量化先验经验的情况下使用混合先验、涉及两种或更多种实验治疗的随机II期选择试验,以及用于涉及多个机构的应用的成组序贯监测试验。