Simultaneously investigating multiple treatments in a single study achieves considerable efficiency in contrast to the traditional two-arm trials.Balancing treatment allocation for influential covariates has become in...Simultaneously investigating multiple treatments in a single study achieves considerable efficiency in contrast to the traditional two-arm trials.Balancing treatment allocation for influential covariates has become increasingly important in today’s clinical trials.The multi-arm covariate-adaptive randomized clinical trial is one of the most powerful tools to incorporate covariate information and multiple treatments in a single study.Pocock and Simon’s procedure has been extended to the multi-arm case.However,the theoretical properties of multi-arm covariate-adaptive randomization have remained largely elusive for decades.In this paper,we propose a general framework for multi-arm covariate-adaptive designs which also includes the two-arm case,and establish the corresponding theory under widely satisfied conditions.The theoretical results provide new insights into the balance properties of covariate-adaptive randomization procedures and make foundations for most existing statistical inferences under two-arm covariate-adaptive randomization.Furthermore,these open a door to study the theoretical properties of statistical inferences for clinical trials based on multi-arm covariateadaptive randomization procedures.展开更多
基金supported by the National Key R&D Program of China (Grant No.2018YFC2000302)National Natural Science Foundation of China (Grant Nos.11731012,11731011 and 12031005)+1 种基金Ten Thousands Talents Plan of Zhejiang Province (Grant No.2018R52042)the Fundamental Research Funds for the Central Universities。
文摘Simultaneously investigating multiple treatments in a single study achieves considerable efficiency in contrast to the traditional two-arm trials.Balancing treatment allocation for influential covariates has become increasingly important in today’s clinical trials.The multi-arm covariate-adaptive randomized clinical trial is one of the most powerful tools to incorporate covariate information and multiple treatments in a single study.Pocock and Simon’s procedure has been extended to the multi-arm case.However,the theoretical properties of multi-arm covariate-adaptive randomization have remained largely elusive for decades.In this paper,we propose a general framework for multi-arm covariate-adaptive designs which also includes the two-arm case,and establish the corresponding theory under widely satisfied conditions.The theoretical results provide new insights into the balance properties of covariate-adaptive randomization procedures and make foundations for most existing statistical inferences under two-arm covariate-adaptive randomization.Furthermore,these open a door to study the theoretical properties of statistical inferences for clinical trials based on multi-arm covariateadaptive randomization procedures.
