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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)
Cesar Daniel Torres, PHD, MS
Senior Mathematical Statistician, OB, OTS, CDER , FDA, United States
Speaker
J. Kyle Wathen, PHD, MS
Vice President, Scientific Strategy and Product Innovation, Cytel Inc., United States
Improving Efficiencies in Drug Development Through a Platform Trial
Robert A. Beckman, MD
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, United States
Efficiency and Type I Error Control of a Generalized Confirmatory Basket Trial Design
Yi Liu, PHD
Vice President, Biometrics, Nektar Therapeutics, United States
Complex Sample Size Re-Estimation Designs in Pivotal Trials and its Impact on Return on Investment
Gregory Levin, PHD
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Panelist
Nora E Carbine
Georgetown Breast Cancer Advocate, Georgetown Lombardi Cancer Center , United States
Panelist