Exact properties of Efron's biased coin randomization procedure
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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.
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Cites work
- scientific article; zbMATH DE number 1817583 (Why is no real title available?)
- scientific article; zbMATH DE number 3911522 (Why is no real title available?)
- scientific article; zbMATH DE number 3249395 (Why is no real title available?)
- A New ‘Biased Coin Design’ for the Sequential Allocation of Two Treatments
- A theoretical analysis of the power of biased coin designs
- Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trials.
- Biased coin design with imbalance tolerance
- Design for the Control of Selection Bias
- Efron's conjecture on vulnerability to bias in a method for balancing sequential trials
- Forcing a sequential experiment to be balanced
- Nonparametric Tests Under Restricted Treatment-Assignment Rules
- Significance tests with restricted randomization design
- Some Restricted randomization rules in sequential designs
- The adaptive biased coin design for sequential experiments
- The doubly adaptive biased coin design for sequential clinical trials
Cited in
(13)- Nonparametric Tests Under Restricted Treatment-Assignment Rules
- 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
- Sequential monitoring with conditional randomization tests
- Generalized Efron's biased coin design and its theoretical properties
- A response-driven adaptive design based on the Klein urn
- New indicators of imbalance and selection bias in randomized sequential designs: comparison of various \`\` biased coin designs.
- 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
- A random walk approach for deriving exact expressions for probabilities associated with Efron's biased coin design
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