In recent drug development, master protocol has been recognized as a methodologic innovation. Commonly known master protocol has been applied to umbrella, basket and platform trials during the investigational stage of a drug or drugs development. In this paper, we present a master protocol design in a post-approval setting. Specifically, medical practice after drug approval must be a key element for any proposed novel design to be of relevance, practical and feasible to implement. We will give rationales, present a variety of scenarios with examples from Division of Medical Imaging and compare their utilities. Some analytical approaches will also be discussed.
*This abstract reflects the views of the author and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.