title: A Unified Family of Covariate-Adjusted Response-Adaptive Designs Based on Efficiency and Ethics.
abstract: Response-adaptive designs have recently attracted more and more attention in the literature because of its advantages in efficiency and medical ethics. To develop personalized medicine, covariate information plays an important role in both design and analysis of clinical trials. A challenge is how to incorporate covariate information in response-adaptive designs while considering issues of both efficiency and medical ethics. To address this problem, we propose a new and unified family of covariate-adjusted response-adaptive (CARA) designs based on two general measurements of efficiency and ethics. Important properties (including asymptotic properties) of the proposed procedures are studied under categorical covariates. This new family of designs not only introduces new desirable CARA designs, but also unifies several important designs in the literature. We demonstrate the proposed procedures through examples, simulations, and a discussion of related earlier work.
authors.affiliation: Associate Professor, Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1402.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Hu
authors.affiliation: Assistant Professor, Division of Biostatistics, The University of Texas School of Public Health, Houston, TX 77030.
authors.forename: Hongjian
authors.initials: H
authors.lastname: Zhu
authors.affiliation: Professor, Department of Statistics, George Washington University, Washington, DC 20052.
authors.forename: Feifang
authors.initials: F
authors.lastname: Hu
keywords: Asymptotic properties; clinical trial; generalized linear models; personalized medicine; power; response-adaptive randomization