The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials
Abstract
Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided.
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Counterbalance was completed in blocks to ensure equal distribution of condition states for simulation condition and equal numbers of resident and attending physician slots.
“Counterbalance was completed in blocks to ensure equal distribution of condition states for simulation condition, and an equal number of slots was allocated to resident and attending physicians.31”
From Impact of Mobile Device-Based Clinical Decision Support Tool on Guideline Adherence and Mental Workload (2019) · cites this paper as [31]
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- Authors
- Lin, Y., Zhu, M., & Su, Z.
- Affiliations
- Takeda (United States) (US)
- Deerfield (United States) (US)
- Corresponding author
- Lin, Yunzhi
- ORCID
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2015-11
- Volume
- 45
- Issue
- Pt A
- Pages
- 21-25
- ISSN
- 1551-7144 (ISSN-L)
- OpenAlex
- W970855755
- Cited by
- 152
- References
- 46
- Citations by year
- 2026: 16 · 2025: 23 · 2024: 19 · 2023: 24 · 2022: 17 · 2021: 13 · 2020: 13 · 2019: 10 · 2018: 10 · 2017: 5 · 2016: 2
- FWCI
- 0.95
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Management Science and Operations Research › Optimal Experimental Design Methods
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- covariate-adaptive randomization, covariate balance, prognostic factors, block randomization, stratified randomization, minimization, treatment allocation, selection bias, clinical trial design
- MeSH terms
- Computer Simulation, Humans, Random Allocation, Research Design, Selection Bias, Randomized Controlled Trials as Topic
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