Comparison of Pocock and Simon's covariate-adaptive randomization procedures in clinical trials.

Comparison of Pocock and Simon's covariate-adaptive randomization procedures in clinical trials.
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DOI:
10.1186/s12874-024-02151-3
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发表时间:
2024-01-25
影响因子:
4
通讯作者:
--
中科院分区:
医学3区
文献类型:
--
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当临床试验中需要平衡多个有影响力的协变量时,在试验中经常使用分层区组随机化和协变量自适应随机化程序,以防止偏倚,提高数据分析结果的有效性。后一种方法在实践中越来越多地用于具有多个协变量和有限样本量的研究。在一组这些方法中,Pocock和Simon提出的协变量自适应程序是直接用于实践的。我们的目的是研究他们开发的三种方法的患者治疗分配概率的最佳设计参数。此外,我们还试图回答在现有随机化程序中添加额外协变量时与随机化性能相关的问题。我们进行了广泛的模拟研究,以解决这些实际上重要的问题。
When multiple influential covariates need to be balanced during a clinical trial, stratified blocked randomization and covariate-adaptive randomization procedures are frequently used in trials to prevent bias and enhance the validity of data analysis results. The latter approach is increasingly used in practice for a study with multiple covariates and limited sample sizes. Among a group of these approaches, the covariate-adaptive procedures proposed by Pocock and Simon are straightforward to be utilized in practice. We aim to investigate the optimal design parameters for the patient treatment assignment probability of their developed three methods. In addition, we seek to answer the question related to the randomization performance when additional covariates are added to the existing randomization procedure. We conducted extensive simulation studies to address these practically important questions.
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