A Bayesian response-adaptive covariate-balanced randomization design with application to a leukemia clinical trial.

A Bayesian response-adaptive covariate-balanced randomization design with application to a leukemia clinical trial.
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DOI:
10.1002/sim.4218
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发表时间:
2011-05-20
影响因子:
2
通讯作者:
Liu, Suyu
Liu, Suyu
中科院分区:
医学3区
文献类型:
--
作者:
Yuan, Ying;Huang, Xuelin;Liu, Suyu

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我们提出一种贝叶斯反应-自适应协变量平衡随机化设计用于多组比较临床试验。设计的目标是使分配概率偏向于更有效的治疗组,同时平衡各治疗组间协变量的分布。特别是,我们首先提出了一种新的基于预后评分的协变量自适应随机化方法,该方法可以自然地容纳连续和分类预后因素,并根据它们在响应预测中的重要性自动为协变量分配不平衡权重。然后,我们将此协变量自适应设计纳入组顺序响应自适应随机化方案。由此产生的响应自适应协变量平衡随机化设计结合了协变量自适应和响应自适应随机化的优点,满足了设计目标。我们通过其在II期白血病临床试验中的应用来说明所提出的设计,并通过模拟研究评估其操作特性。
We propose a Bayesian response-adaptive covariate-balanced randomization design for multiple-arm comparative clinical trials. The goal of the design is to skew the allocation probability to more efficacious treatment arms, while also balancing the distribution of the covariates across the arms. In particular, we first propose a new covariate-adaptive randomization method based on a prognostic score that naturally accommodates continuous and categorical prognostic factors and automatically assigns imbalance weights to covariates according to their importance in response prediction. We then incorporate this covariate-adaptive design into a group sequential response-adaptive randomization scheme. The resulting response-adaptive covariate-balanced randomization design combines the advantages of both covariate-adaptive and response-adaptive randomizations and meets the design goal. We illustrate the proposed design through its application to a phase II leukemia clinical trial, and evaluate its operating characteristics through simulation studies.
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