A random allocation system with the minimization method for multi-institutional clinical trials.

This paper describes the random allocation system used to perform precise and rapid treatment assignments in multi-institutional clinical trials. This system is based on sophisticated randomization procedures, according to Pocock and Simon's minimization method and Zelen's method for institution balancing. The major advantage of randomized treatment assignments with this system is to balance treatment numbers for each level of various prognostic factors over the entire trial and at the same time balance the allocation of treatments within an institution. Therefore, the randomized treatment assignments by this system can prevent degrading of the statistical power of a particular treatment factor. This system is designed to run on a small-sized notebook computer and therefore can be set up beside a telephone for registration, without occupying a large space. At present, this system is conveniently being used in two clinical trials.