ABSTRACT

This chapter illustrates the mechanisms of the Maximum Tolerable Indifference (MTI) procedures based on the conditional allocation probability. It aims to compare their performance with each other based on the treatment assignment predictability. To avoid the unwanted imbalances resulting from the complete randomization, various restricted randomization procedures have been proposed aiming to have equal number of subjects assigned to each treatment arm. The primary goal of restricted randomization is to control the treatment distribution imbalance. It is a natural strategy to alter the treatment allocation probability according to the observed treatment distribution. Different randomization designs may have been illustrated by different models. Statistical properties of randomization designs are usually evaluated based on treatment imbalance and allocation randomness. A computerized subject randomization module is integrated with the clinical trial management and electronic data capture system, so that a treatment assignment is generated at real time whenever an eligible subject is ready for randomization.