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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
Senior Mathematical Statistician, OB, OTS, CDER , FDA, United States
Improving Efficiencies in Drug Development Through a Platform Trial
Vice President, Scientific Strategy and Product Innovation, Cytel Inc., United States
Efficiency and Type I Error Control of a Generalized Confirmatory Basket Trial Design
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, United States
Complex Sample Size Re-Estimation Designs in Pivotal Trials and its Impact on Return on Investment
Vice President, Biometrics, Nektar Therapeutics, United States
Panelist
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Panelist
Georgetown Breast Cancer Advocate, Georgetown Lombardi Cancer Center , United States
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