Randomized Designs for Early Trials of New Cancer Treatments—an Overview

This paper argues that randomization should more often be considered for early trials of experimental cancer treatments. Uncontrolled as well as randomized designs for Phase II trials are reviewed. The severe limitations of uncontrolled designs are illustrated, and possible difficulties with randomized designs discussed. It is argued that in randomized Phase II trials, the treatment allocation method should be chosen to achieve good balance with respect to the most important prognostic factors.