Exact properties of Efron's biased coin randomization procedure

DOI10.1214/09-AOS758zbMATH Open1189.62130arXiv1010.0483OpenAlexW2067581059MaRDI QIDQ973877FDOQ973877

Authors: Tigran Markaryan, William F. Rosenberger 

Publication date: 26 May 2010

Published in: The Annals of Statistics (Search for Journal in Brave)

Abstract: Efron [Biometrika 58 (1971) 403--417] developed a restricted randomization procedure to promote balance between two treatment groups in a sequential clinical trial. He called this the biased coin design. He also introduced the concept of accidental bias, and investigated properties of the procedure with respect to both accidental and selection bias, balance, and randomization-based inference using the steady-state properties of the induced Markov chain. In this paper we revisit this procedure, and derive closed-form expressions for the exact properties of the measures derived asymptotically in Efron's paper. In particular, we derive the exact distribution of the treatment imbalance and the variance-covariance matrix of the treatment assignments. These results have application in the design and analysis of clinical trials, by providing exact formulas to determine the role of the coin's bias probability in the context of selection and accidental bias, balancing properties and randomization-based inference.

Full work available at URL: https://arxiv.org/abs/1010.0483

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zbMATH Keywords

randomization testselection biasrestricted randomizationaccidental biasexact distribution theory

Mathematics Subject Classification ID

Exact distribution theory in statistics (62E15) Applications of statistics to biology and medical sciences; meta analysis (62P10) Sequential statistical design (62L05) Design of statistical experiments (62K99)

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Cited In (12)

• Selecting a biased-coin design
• Asymptotic properties of covariate-adaptive randomization
• Conditioning Efron's biased coin design to ensure final balance
• Power efficiency of Efron's biased coin design
• Generalized Efron's biased coin design and its theoretical properties
• Sequential monitoring with conditional randomization tests
• New indicators of imbalance and selection bias in randomized sequential designs: comparison of various \`\` biased coin designs.
• A response-driven adaptive design based on the Klein urn
• Covariate‐adjusted response adaptive designs incorporating covariates with and without treatment interactions
• Multi-arm covariate-adaptive randomization
• Adaptive clinical trial designs to detect interaction between treatment and a dichotomous biomarker
• Nonparametric Tests Under Restricted Treatment-Assignment Rules

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