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Covariate-adaptive designs with missing covariates in clinical trials

Covariate-adaptive designs with missing covariates in clinical trials
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摘要 Many covariate-adaptive randomization procedures have been proposed and implemented to balance important covariates in clinical trials. These methods are usually based on fully observed covariates. In practice,the covariates of a patient are often partially missing. We propose a novel covariate-adaptive design to deal with missing covariates and study its properties. For the proposed design, we show that as the number of patients increases, the overall imbalance, observed margin imbalance and fully observed stratum imbalance are bounded in probability. Under certain covariate-dependent missing mechanism, the proposed design can balance missing covariates as if the covariates are observed. Finally, we explore our methods and theoretical findings through simulations. Many covariate-adaptive randomization procedures have been proposed and implemented to balance important covariates in clinical trials. These methods are usually based on fully observed covariates. In practice,the covariates of a patient are often partially missing. We propose a novel covariate-adaptive design to deal with missing covariates and study its properties. For the proposed design, we show that as the number of patients increases, the overall imbalance, observed margin imbalance and fully observed stratum imbalance are bounded in probability. Under certain covariate-dependent missing mechanism, the proposed design can balance missing covariates as if the covariates are observed. Finally, we explore our methods and theoretical findings through simulations.
出处 《Science China Mathematics》 SCIE CSCD 2015年第6期1191-1202,共12页 中国科学:数学(英文版)
基金 supported by National Natural Science Foundation of China(Grant Nos.11371366 and 11201479) Research Fund for the Doctoral Program of Higher Education of China(Grant No.20120004120007) the Basic Research Funds in Renmin University of China from the central government(Grant Nos.13XNLJ03 and 12XNQ049)
关键词 missing stratum imbalance restored strata absolute partially minimization margin exclusive 自适应设计 协变量 临床试验 平衡重 适应性 不平衡 利润率 依赖性
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参考文献22

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