Online Program

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All Times EDT

Wednesday, September 23
Wed, Sep 23, 11:30 AM - 12:45 PM
Virtual
Promotion of Innovative Adaptive Strategies in Clinical Trials Through Statistical Methodologies

Covariate-Adaptive Randomization Through Algorithms for Minimization and the Implementation with an R Package (301241)

*Jonathan Hartzel, Merck 

Keywords: Covariate adaptive randomization, minimization.

Randomization is an established process to assign participants to treatment groups to reduce selection bias. Minimization is a method of dynamic or adaptive randomization to minimize the imbalance between treatment groups with respect to the number of participants over the participant’s predefined covariate factors. The algorithms for minimization randomization with equal allocation ratio have been well studied in the literature. With the growing demand for unequal allocation in clinical trials, an allocation ratio preserving biased coin minimization (ARP BCM) was proposed to preserve the allocation ratio at every allocation step, using measure of imbalance by the range. In this talk the expansion of the ARP BCM to unequal allocation will be discussed, which preserves the allocation ratio at every allocation, using measures of imbalance by the standard deviation and variance. Simulations conducted to evaluate the performance of these methods will be reviewed, as well as an R package, ‘Minirand’, that performs the covariate-adaptive randomization.