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Operationalizing Master Protocols
Session Chair(s)
MaryAnn Morgan-Cox, PhD
Senior Director, Immunology Design Hub
Eli Lilly and Company, United States
The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (including basket, umbrella, and platform trials) provide a method to answer multiple questions in one overarching trial structure. Although these trials require more intentional planning, coordination and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial.
In this session, we consider this emerging family of clinical trial designs within the context of broader efforts to increase efficiency, effectiveness, and quality in the development paradigm.
Learning Objective : Analyze different trial designs that can be described and executed under a master protocol (including umbrella, basket and platform); Describe considerations and challenges for master protocol development; Discuss a case example for using the common protocol template basket studies; Identify critical elements around data collection, analysis, and interpretation;
Speaker(s)
Master Protocols; Design and Execution Considerations
Meredith Buxton, PhD, MPH
Global Coalition For Adaptive Research, United States
Chief Executive Officer
Utilizing the TransCelerate Common Protocol Template for Novel Clinical Trial Designs, Such as Platform Trials
Mitzi Allred, PhD
Merck & Co., Inc, United States
Director, Clinical Operations
Statistical Analysis Opportunities and Challenges with Master Protocols
Karen Lynn Price, PhD
Eli Lilly and Company, United States
Senior Research Fellow, Statistical Innovation Center/Design Hub
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