An Overview of Phase II Clinical Trial Designs
Abstract
Clinical trials are studies to test new treatments in humans. Typically, these treatments are evaluated over several phases to assess their safety and efficacy. Phase I trials are designed to evaluate the safety and tolerability of a new treatment, typically with a small number of patients (e.g., 20–80), generally spread across several dose levels. Phase II trials are designed to determine if the new treatment has sufficiently promising efficacy to warrant further investigation in a large-scale randomized phase III trial, as well as to further assess safety. These studies usually involve a few hundred patients. This article provides an overview of some of the most commonly used phase II designs for clinical trials and emphasize their critical elements and considerations. Key references to some of the most commonly used phase II designs are given to allow the reader to explore at more detail the critical aspects when planning a phase II trial. A comparison of three potential designs in the context of the NRG-HN002 trial is presented to complement the discussion about phase II trials.
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