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Session 10 – Adaptive Design: New FDA Experiences
Session Chair(s)
Jerald Schindler, DrPH
Chief Executive Officer
Strategic Statistics, United States
Rajeshwari Sridhara, PhD
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA
FDA, United States
This session will explore the recent successful uses of Adaptive Design during the drug development process. We will also explore the recent trend towards the increased use of adaptive designs in late development as well as expanded use of Bayesian methods. These discussions will include strategies for successful adaptive design planning with appropriate early simulations to define the operating characteristics. We will also discuss the requirement to ensure that any late stage adaptive designs allow sufficient flexibility and also are rigorous enough to be considered “adequate and well controlled.”
Speaker(s)
FDA Oncology Experience in Innovative Adaptive Trial Designs
Rajeshwari Sridhara, PhD
FDA, United States
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA
Adaptive Population Enrichment for Oncology Trials
Cyrus R. Mehta, PhD, MSc
Cytel Inc., United States
Founder and President
Panelist
Lisa LaVange, PhD
University of North Carolina at Chapel Hill, United States
Professor Emerita
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