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The randomized comparative clinical trial has been recognized as the most credible research design for clinical investigation. Adaptive randomization is a class of randomization designs for which treatment allocation probabilities are sequentially modified based on accumulating data in the trial to achieve selected experimental objectives while maintaining the validity and integrity of the trial results. Depending on the trial objectives, one can distinguish four major types of adaptive randomization: restricted, covariate–adaptive, response–adaptive, and covariate-adjusted response–adaptive. The differential feature of each type is the data structure that forms the basis for design adaptations, from the simplest one, which includes a history of study patients’ treatment assignments (restricted randomization), to the most complex one, which includes a history of study patients’ treatment assignments, covariates, responses, and a covariate profile of the current patient (covariate-adjusted response–adaptive randomization).
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