4 Types Of Dose Finding Studies Used In Phase II Clinical Trials

By Dr. Karen Kesler, Senior Statistical Scientist

One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high enough to demonstrate efficacy in the target population, yet low enough to minimize safety concerns and adverse  events. There are a number of strategies to determine the optimal dose, but here we will look at the four most common dose finding study designs.