Cited by 2,350Statistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesOptimal Experimental Design Methods

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Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial

Pocock, Stuart J., Simon, Richard·1975·Biometrics

DOI 10.2307/2529712

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Abstract

In controlled clinical trials there are usually several prognostic factors known or thought to influence the patient's ability to respond to treatment. Therefore, the method of sequential treatment assignment needs to be designed so that treatment balance is simultaneously achieved across all such patients factor. Traditional methods of restricted randomization such as "permuted blocks within strata" prove inadequate once the number of strata, or combinations of factor levels, approaches the sample size. A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor. The improved treatment balance obtained by this approach is explored using simulation for a simple model of a clinical trial. Further discussion centers on the selection, predictability and practicability of such a procedure.

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Forcing a sequential experiment to be balanced
EFRON, B. (1971) · Biometrika · doi:10.1093/biomet/58.3.403 · Cited by 873

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Authors: Pocock, S. J., & Simon, R.
ORCID: Pocock, Stuart J.
Simon, Richard
Venue: Biometrics
Publisher: JSTOR
Published: 1975-03
Volume: 31
Issue: 1
Pages: 103
ISSN: 0006-341X (ISSN-L)
DOI: 10.2307/2529712
OpenAlex: W2000366267
Cited by: 2,350
References: 1
Citations by year: 2026: 67 · 2025: 90 · 2024: 84 · 2023: 93 · 2022: 84 · 2021: 94 · 2020: 100 · 2019: 93 · 2018: 95 · 2017: 102 · 2016: 100 · 2015: 82 · 2014: 105 · 2013: 88 · 2012: 119
FWCI: 9.36
Type: journal article
Language: en
Open access: closed
Locations: Biometrics (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Social Sciences › Decision Sciences › Management Science and Operations Research › Optimal Experimental Design Methods
Keywords: prognostic factors, restricted randomization, stratified randomization, clinical trials
MeSH terms: Carmustine, Clinical Trials as Topic, Cyclophosphamide, Evaluation Studies as Topic, Humans, Lymphoma, Models, Theoretical, Prednisone, Prognosis, Statistics as Topic, Vincristine

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Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial

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