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Bayesian Adaptive Randomization Design

The Bayesian adaptive randomization design is an extension of adaptive research designs, which modify the randomization ratio during a study in order to maximize individual participant outcomes. Bayesian adaptive randomization designs use Bayesian data analysis to estimate the probability that each intervention maximizes the outcome of interest, and the randomization ratio is adjusted according to these estimates. In adjusting the randomization ratio based on which intervention is estimated to produce the most favorable outcome, Bayesian adaptive randomization designs maximize the likelihood of participants experiencing positive outcomes and minimize the likelihood of participants experiencing poor outcomes.

Bayesian adaptive randomization designs follow a four-step procedure. In Step 1, participants are randomly allocated to one of the interventions with the probability of allocation into each intervention being specified by the randomization ratio. In Step 2, participants’ outcome data are collected. In Step 3, the probability that each intervention produces the most favorable outcome is estimated with Bayesian data analysis. In Step 4, the randomization ratio is updated. Steps 1–4 are then repeated until either the desired number of participants has been recruited or one of the interventions has shown convincing evidence of producing the most favorable outcome.

This entry goes on to provide an examination of adaptive randomization ratios, two primary assumptions made by Bayesian adaptive randomization design, and logical considerations. Various types of data used in Bayesian data analysis are introduced, and the steps of early and late randomizations are then explained. The entry concludes by listing some advantages and limitations of Bayesian adaptive randomization design, followed by an example of a hypothetical study implementing a two-group Bayesian adaptive randomization design.

Adaptive Randomization Ratios

Most randomized study designs use a fixed randomization ratio, but Bayesian adaptive randomization designs implement an adaptive randomization ratio. A randomization ratio is defined as a ratio of the probabilities of being randomly allocated to each of the interventions. A fixed randomization ratio is held constant throughout the study, but an adaptive randomization ratio can change during the study.

To better understand randomization ratios—both fixed and adaptive—consider a two-group study. In this example and throughout the remainder of this entry, it is assumed that each group is implementing a different intervention. Researchers may consider a research design using a 1:1 fixed randomization ratio, which indicates a 50% chance a participant is allocated into the first group and a 50% chance a participant is allocated into the second group. Researchers may also consider a research design using an adaptive randomization ratio. The adaptive randomization ratio may be 1:1 during the early stages of the study, but the randomization ratio could change during the course of the study if collected data indicate one of the groups’ interventions produces better outcomes.

Assumptions

Bayesian adaptive randomization designs make two primary assumptions. First, the randomization of participants must be dispersed throughout the course of the study, such that the outcome data collection for some participants occurs before the randomization of other participants. Because Bayesian adaptive randomization designs use participants’ results to inform future randomizations, some participants must be randomized after collecting data from previous participants to maximize individual participant outcomes. If all the participants are randomized simultaneously, Bayesian adaptive randomization designs replicate fixed randomization designs, which would likely fail to maximize individual participant outcomes.

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