Covariate-Adaptive Biased Coin Randomization for Master Protocols with Multiple Interventions and Biomarker-Stratified Allocation

被引：1

作者：

Song, Tianhao ^{[1
]}

Lavange, Lisa M. ^{[1
]}

Ivanova, Anastasia ^{[1
]}

机构：

[1] Univ N Carolina, Dept Biostat, CB 7420, Chapel Hill, NC 27599 USA

来源：

STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2024年 / 16卷 / 04期

关键词：

Biased coin design; Biomarker-positive subgroup; Covariate-adaptive randomization; Enrichment; SEVERE ASTHMA; DESIGN; TRIAL;

D O I：

10.1080/19466315.2023.2268313

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

In a multi-arm trial with predefined subgroups for each intervention to target, it is often desirable to enrich assignment to an intervention by enrolling more biomarker-positive participants to the intervention. We describe how to implement a biased coin design to achieve desired allocation ratios among interventions and between the number of biomarker-positive and biomarker-negative participants assigned to each intervention. We illustrate the proposed method with the randomization algorithm implemented in the Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) trial.

引用

页码：526 / 531

页数：6

共 10 条

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