Randomization in clinical trials: Conclusions and recommendations

Lachin, John M.; Matts, John P.; Wei, L.J.

doi:10.1016/0197-2456(88)90049-9

Cited by 272Statistical Methods in Clinical TrialsOptimal Experimental Design MethodsAdvanced Causal Inference Techniques

Randomization in clinical trials: Conclusions and recommendations

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Lachin, John M., Matts, John P., Wei, L.J.·1988·Controlled Clinical Trials

DOI 10.1016/0197-2456(88)90049-9

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Abstract

The statistical properties of simple (complete) randomization, permuted-block (or simply blocked) randomization, and the urn adaptive biased-coin randomization are summarized. These procedures are contrasted to covariate adaptive procedures such as minimization and to response adaptive procedures such as the play-the-winner rule. General recommendations are offered regarding the use of complete, permuted-block, or urn randomization. In a large double-masked trial, any of these procedures may be acceptable. For a given trial, the relative merits of each procedure should be carefully weighed in relation to the characteristics of the trial. Important considerations are the size of the trial, overall as well as within the smallest subgroup to be employed in a subgroup-specific analysis, whether or not the trial is to be masked, and the resources needed to perform the proper randomization-based permutational analysis.

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Randomization was performed by the coordinating center using the simple urn method, stratified by clinical center.
“Women who met these criteria were randomly assigned by the coordinating center, with the use of the simple urn method,11 stratified by clinical center.”
From A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes (2009) · cites this paper as [11]
Youth with LOC participating in study 3 are randomized according to a permuted block design to CBT-E or INTER-E first.
“Youth with LOC participating in study 3 are randomized according to a permuted block design [46] to CBT-E or INTER-E first.”
From Correlates of interpersonal emotion regulation problems in Loss of Control eating (LOC) in youth: study protocol of the combined online and App based questionnaire, laboratory and randomized controlled online intervention i-BEAT trial (2021) · cites this paper as [46]

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Authors: Lachin, J. M., Matts, J. P., & Wei, L. J.
Affiliations: George Washington University (US)
University of Minnesota (US)
University of Michigan (US)
Corresponding author: Lachin, John M.
ORCID: Lachin, John M.
Wei, L.J.
Venue: Controlled Clinical Trials
Publisher: Elsevier BV
Published: 1988-12
Volume: 9
Issue: 4
Pages: 365-374
ISSN: 0197-2456 (ISSN-L)
DOI: 10.1016/0197-2456(88)90049-9
OpenAlex: W2001307401
Cited by: 272
References: 13
Citations by year: 2026: 6 · 2025: 2 · 2024: 8 · 2023: 12 · 2022: 8 · 2021: 20 · 2020: 13 · 2019: 16 · 2018: 13 · 2017: 8 · 2016: 17 · 2015: 13 · 2014: 13 · 2013: 13 · 2012: 13
FWCI: 2.93
Type: journal article
Language: en
Open access: green
hdl.handle.net
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Controlled Clinical Trials (publishedVersion)
PubMed (publishedVersion)
Deep Blue (University of Michigan) (submittedVersion)
Funders: National Institutes of Health (5r01am027769-05, 5r01dk039826-05)
National Institute of Diabetes and Digestive and Kidney Diseases (R01-DK-39826, N01-DK-2-2206)
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: randomization, permuted block randomization, covariate-adaptive randomization, minimization, response-adaptive randomization, subgroup analysis
MeSH terms: Clinical Trials as Topic, Humans, Random Allocation, Research Design, Models, Statistical

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