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Activity Number: 115 - Novel Statistical Methods for Emerging Problems in Modern Clinical Trials and Drug Development
Type: Topic Contributed
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #306483
Title: Master Protocol and Designs for Setting Where Randomized Controlled Trials Are Not Feasible*
Author(s): Sue-Jane Wang*
Companies: Center for Drug Evaluation and Research U.S. Food and Drug Administration
Keywords: master protocol; post marketing requirement; medical imaging

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.

Authors who are presenting talks have a * after their name.

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