Asymptotic properties of covariate-adjusted response-adaptive designs

• 成果类型: Article
• 署名作者: Zhang, Li-Xin; Hu, Feifang; Cheung, Siu Hung; Chan, Wai Sum
• 署名单位: Zhejiang University; Chinese University of Hong Kong; University of Virginia; Chinese University of Hong Kong
• 刊物名称: ANNALS OF STATISTICS
• ISSN/ISSBN: 0090-5364
• DOI: 10.1214/009053606000001424
• 发表日期: 2007
• 页码: 1166-1182
• 关键词: biased-coin designs; sequential clinical-trials; play-winner rule; randomization; allocation; likelihood

摘要

Response-adaptive designs have been extensively studied and used in clinical trials. However, there is a lack of a comprehensive study of responseadaptive designs that include covariates, despite their importance in clinical trials. Because the allocation scheme and the estimation of parameters are affected by both the responses and the covariates, covariate-adjusted responseadaptive (CARA) designs are very complex to formulate. In this paper, we overcome the technical hurdles and lay out a framework for general CARA designs for the allocation of subjects to K (>= 2) treatments. The asymptotic properties are studied under certain widely satisfied conditions. The proposed CARA designs can be applied to generalized linear models. Two important special cases, the linear model and the logistic regression model, are considered in detail.