A Unified Family of Covariate-Adjusted Response-Adaptive Designs Based on Efficiency and Ethics

• 成果类型: Article
• 署名作者: Hu, Jianhua; Zhu, Hongjian; Hu, Feifang
• 署名单位: University of Texas System; UTMD Anderson Cancer Center; University of Texas System; University of Texas Health Science Center Houston; University of Texas School Public Health; George Washington University
• 刊物名称: JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION
• ISSN/ISSBN: 0162-1459
• DOI: 10.1080/01621459.2014.903846
• 发表日期: 2015
• 页码: 357-367
• 关键词: biased coin designs; clinical-trials; asymptotic properties; prognostic-factors; randomization procedures; atrial-fibrillation; Optimal allocation; stroke prevention; winner rule; cancer

摘要

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.