4 Types Of Efficacy Outcomes To Consider In Phase II Clinical Trials

By Dr. Karen Kesler and Dr. Andrea Mospan

You will often hear the phrase “learn and confirm” related to clinical trials. Phase II clinical trials are where you “learn” about your treatment and phase III clinical trials are where you “confirm” what you know for regulatory agencies. One important part of the learning that takes place in phase II is looking at various efficacy outcomes to determine which primary end point you will use for phase III and what specific label claims you will be able to make following an approved NDA.