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Master Protocols: Applications in Oncology
Session Chair(s)
Amy Xia, PhD
Vice President, Center for Design and Analysis
Amgen Inc., United States
Future advances in medicine depend on our ability to leverage complex innovative designs of clinical trials. Master protocols, including basket, umbrella, and platform trials, as one type of complex innovative designs, provide a method to answer multiple questions in one overall trial structure. In this session, the concept of master protocols, some case studies using real world examples in oncology, and the advantages and challenges of designing and implementing master protocols will be discussed. Join the Statistics Community for a follow up Round Table discussion on Wednesday, June 26, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.
Learning Objective : Explain the concept of master protocols; Discuss case studies in master protocols with applications in oncology; Describe opportunities and challenges in applying master protocols as an innovative approach in oncology drug development.
Speaker(s)
FDA Update
Yuan-Li Shen, DrPH
FDA, United States
Division Director, Division of Biometrics IX, OB, OTS, CDER
Industry Update
Scott Berry, PhD
Berry Consultants LLC, United States
President and Senior Statistical Scientist
Industry Perrspective About Platform Trials
Karen Lynn Price, PhD
Eli Lilly and Company, United States
Senior Research Fellow, Statistical Innovation Center/Design Hub
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