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Activity Number:
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23
- Increasing Efficiency and Integrity of Randomized Trials: Covariate-Adjusted Randomization and Monitoring Patient Accrual and Selection Bias
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 30, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323561
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Title:
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Balanced Covariates with Response Adaptive Randomization
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Author(s):
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Benjamin Saville*
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Companies:
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Berry Consultants
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Keywords:
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Response adaptive randomization ;
clinical trial ;
covariate balance ;
imbalance ;
stratification ;
Bayesian RAR
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Abstract:
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Response adaptive randomization (RAR) methods for clinical trials are susceptible to imbalance in the distribution of influential covariates across treatment arms. This can make the interpretation of trial results difficult, because observed differences between treatment groups may be a function of the covariates and not necessarily due to the treatments themselves. We propose a method for balancing the distribution of covariate strata across treatment arms within RAR. The method uses odds ratios to modify global RAR probabilities to obtain stratum-specific modified RAR probabilities. We provide illustrative examples and a simple simulation study to demonstrate the effectiveness of the strategy for maintaining covariate balance. The proposed method is straightforward to implement and applicable to any type of RAR method or outcome.
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Authors who are presenting talks have a * after their name.
