Liu Zhongqiang, Hu Feifang, Zhang Li-Xin
School of Mathematical Sciences, Zhejiang University, Hangzhou, China.
School of Mathematics and Information Science, Henan Polytechnic University, Jiaozuo, China.
Pharm Stat. 2018 Nov;17(6):781-796. doi: 10.1002/pst.1900. Epub 2018 Aug 27.
Many response-adaptive randomization procedures have been proposed and studied over the past few decades. However, most of these procedures are based on parametric structure and do not directly apply to nonparametric models. In this paper, we propose a response-adaptive randomization procedure based on Mann-Whitney U test statistic. Under widely satisfied conditions, we derive asymptotic properties of the randomization procedure and further obtain power functions in form under Mann-Whitney U test. Simulations show the proposed procedure is more robust and more ethical than classical response-adaptive randomization procedures in some circumstances. Advantages of the procedure are also illustrated in a redesigned real clinical trial.
在过去几十年中,人们提出并研究了许多响应自适应随机化程序。然而,这些程序大多基于参数结构,并不直接适用于非参数模型。在本文中,我们提出了一种基于曼-惠特尼U检验统计量的响应自适应随机化程序。在广泛满足的条件下,我们推导了该随机化程序的渐近性质,并进一步得到了曼-惠特尼U检验形式下的功效函数。模拟结果表明,在某些情况下,所提出的程序比经典的响应自适应随机化程序更稳健、更符合伦理。在一项重新设计的真实临床试验中也说明了该程序的优势。