Applied Statistical Unit, Indian Statistical Institute, Kolkata 700108, India.
Stat Methods Med Res. 2012 Aug;21(4):379-92. doi: 10.1177/0962280210385866. Epub 2010 Oct 25.
Response-adaptive designs have become popular for allocation of the entering patients among two or more competing treatments in a phase III clinical trial. Although there are a lot of designs for binary treatment responses, the number of designs involving covariates is very small. Sometimes the patients give repeated responses. The only available response-adaptive allocation design for repeated binary responses is the urn design by Biswas and Dewanji [Biswas A and Dewanji AA. Randomized longitudinal play-the-winner design for repeated binary data. ANZJS 2004; 46: 675-684; Biswas A and Dewanji A. Inference for a RPW-type clinical trial with repeated monitoring for the treatment of rheumatoid arthritis. Biometr J 2004; 46: 769-779.], although it does not take care of the covariates of the patients in the allocation design. In this article, a covariate-adjusted response-adaptive randomisation procedure is developed using the log-odds ratio within the Bayesian framework for longitudinal binary responses. The small sample performance of the proposed allocation procedure is assessed through a simulation study. The proposed procedure is illustrated using some real data set.
响应适应性设计在三期临床试验中已成为一种将进入的患者分配到两种或多种竞争治疗方法的热门方法。尽管有很多用于二进制治疗反应的设计,但涉及协变量的设计数量非常少。有时患者会给出重复的反应。唯一可用的用于重复二进制响应的响应适应性分配设计是 Biswas 和 Dewanji 的 urn 设计[Biswas A 和 Dewanji AA. 用于重复二进制数据的随机纵向胜者设计。ANZJS 2004; 46: 675-684; Biswas A 和 Dewanji A. 用于治疗类风湿关节炎的重复监测的 RPW 型临床试验的推断。Biometr J 2004; 46: 769-779。],尽管它在分配设计中没有考虑患者的协变量。本文在贝叶斯框架内使用对数优势比为纵向二进制响应开发了一种协变量调整的响应适应性随机化程序。通过模拟研究评估了所提出的分配程序的小样本性能。该程序通过一些实际数据集进行了说明。