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Tommy Douglas Conference Center

02 mar 2020 7:00 a.m. - 03 mar 2020 5:15 p.m.

10000 New Hampshire Ave, Silver Spring, MD 20903

DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients

Session 3: Flexible, Efficient Decision-Making: Complex Adaptive Design

Session Chair(s)

Yi  Liu, PhD

Yi Liu, PhD

Vice President, Biometrics

Nektar Therapeutics, United States

Cristiana  Mayer, DrSc, PhD

Cristiana Mayer, DrSc, PhD

Head of Biostatistics

Johnson & Johnson Vision, United States

Gregory  Levin, PhD

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

Speaker

Cesar Daniel Torres, PhD, MS

FDA, United States

Senior Mathematical Statistician, OB, OTS, CDER

J. Kyle  Wathen, PhD, MS

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

Robert A. Beckman, MD

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

Yi  Liu, PhD

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

Gregory  Levin, PhD

Panelist

Gregory Levin, PhD

FDA, United States

Associate Director for Statistical Science and Policy, OB, OTS, CDER

Nora E Carbine

Panelist

Nora E Carbine

Georgetown Lombardi Cancer Center , United States

Georgetown Breast Cancer Advocate

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