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

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...

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Bibliographic Details
Published in:BMC medical research methodology 2024-01, Vol.24 (1), p.22-12, Article 22
Main Authors: Shan, Guogen, Li, Yulin, Lu, Xinlin, Zhang, Yahui, Wu, Samuel S
Format: Article
Language:English
Subjects:
Additional covariates
Allocation predictability
Analysis
Bias
Clinical trials
Clinical Trials as Topic
Computer Simulation
Covariate adaptive randomization
Evaluation
Humans
Imbalance score
Information management
Medical research
Medicine, Experimental
Methods
Pocock and Simon
Probability
Random Allocation
Research Design
Sample Size
Set (Psychology)
Statistical power
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Summary: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.
ISSN:1471-2288
1471-2288
DOI:10.1186/s12874-024-02151-3