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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

  • Executive Director Biostatistics
  • 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

  • Deputy Director, DBIII, 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

  • Mathematical Statistician
  • FDA, United States
J. Kyle Wathen, PhD, MS

Improving Efficiencies in Drug Development Through a Platform Trial

J. Kyle Wathen, PhD, MS

  • Senior Director, Advanced Analytics
  • Gilead Sciences, Inc. , United States
Robert A. Beckman, MD

Efficiency and Type I Error Control of a Generalized Confirmatory Basket Trial Design

Robert A. Beckman, MD

  • Professor of Oncology, Bioinformatics, and Biomathematics
  • Georgetown University Medical Center, United States
Yi Liu, PhD

Complex Sample Size Re-Estimation Designs in Pivotal Trials and its Impact on Return on Investment

Yi Liu, PhD

  • Executive Director Biostatistics
  • Nektar Therapeutics, United States
Gregory Levin, PhD

Panelist

Gregory Levin, PhD

  • Deputy Director, DBIII, OB, OTS, CDER
  • FDA, United States
Nora E Carbine

Panelist

Nora E Carbine

  • Georgetown Breast Cancer Advocate
  • Georgetown Lombardi Cancer Center , United States

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Additional Information

Complex Innovative Clinical Trial Designs Resource Kit

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Recent Regulatory Efforts on Complex Innovative Clinical Trial Design
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