An overview of randomization and minimization programs for randomized clinical trials

Abstract

• Randomization is an essential component of sound clinical trials which prevents selection biases and helps in blinding the allocations. Randomization is a process by which subsequent subjects enrolled into trial groups only by chance which is essentially eliminates selection biases. A serious consequence of randomization is severe imbalance among treatment groups with respect to some prognostic factors, which invalidate the trial results or necessitate complex and usually unreliable secondary analysis to eradicate the source of imbalances. Minimization on the other hand tends to allocate in a way to minimize the differences among groups with respect to prognostic factors. Pure minimization is therefore completely deterministic, that is one can predict the allocation of the next subject by knowing the factor levels of previously enrolled subject and having the properties of the next subject. To eliminate predictability of randomization, it is necessary to include some elements of randomness in the minimization algorithms. In this article brief descriptions of randomization and minimization are presented followed by introducing selected randomization and minimization programs.