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Session 3: Flexible, Efficient Decision-Making: Complex Adaptive Design
Session Chair(s)
Yi Liu, PhD
Vice President, Biometrics
Nektar Therapeutics, United States
Cristiana Mayer, DrSc, PhD
Head of Biostatistics
Johnson & Johnson Vision, United States
Gregory Levin, PhD
Associate Director for Statistical Science and Policy, OB, OTS, CDER
FDA, United States
Novel methods for planning decision-making in Complex Innovative Designs comprise different features of adaptive efficient trials. Efficiency can be viewed from different angles to balance correct decision-making as early as possible for a drug development program with cost-effectiveness and quantification of multiple metrics to measure “success” of a trial. An example of a platform trial in the infectious disease area is presented to illustrate a Bayesian approach to utilize longitudinal data for developing a predictive model for the long-term clinical outcome. In confirmatory settings, the use of a basket trial will be used to illustrate the effect of adaptive trials on cost-effectiveness and feasibility of drug development in rare diseases and/or subgroups of common diseases like cancer. A third presentation will address an optimal sample size adaptation rule that maximizes return on investment, a metric to balance time to market, trial costs, and probability of success.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand essential elements of decision-making in the context of complex adaptive designs
- Recognize different methods and applications of adaptive designs
- Appreciate complexity of decision-making in drug development
Speaker(s)
Speaker
Cesar Daniel Torres, PhD, MS
FDA, United States
Senior Mathematical Statistician, OB, OTS, CDER
Improving Efficiencies in Drug Development Through a Platform Trial
J. Kyle Wathen, PhD, MS
Cytel Inc., United States
Vice President, Scientific Strategy and Product Innovation
Efficiency and Type I Error Control of a Generalized Confirmatory Basket Trial Design
Robert A. Beckman, MD
Georgetown University Medical Center, United States
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics
Complex Sample Size Re-Estimation Designs in Pivotal Trials and its Impact on Return on Investment
Yi Liu, PhD
Nektar Therapeutics, United States
Vice President, Biometrics
Panelist
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Panelist
Nora E Carbine
Georgetown Lombardi Cancer Center , United States
Georgetown Breast Cancer Advocate