Dose Spacing in Early Dose Response Clinical Trial Designs

Finding the right dose or the right range of doses is one of the most important objectives in the clinical development program of a new drug. In designing early Phase 2 dose response studies, one critical question is: “What spacing should be used between test doses?” In this article, we propose an intuitive, model-free approach to address this question. Simulations are performed to compare the proposed design with optimal designs under logistic and normal models. The proposed method for dose allocation can be applied to various types of dose response studies.