Journal
ANNALS OF STATISTICS
Volume 35, Issue 3, Pages 1166-1182Publisher
INST MATHEMATICAL STATISTICS
DOI: 10.1214/009053606000001424
Keywords
adaptive designs; asymptotic normality; clinical trial; covariate information; generalized linear model; logistic regression
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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.
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