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


Session 4: Bayesian Designs: Continuous Learning and Decision-Making

Session Chair(s)

Fanni  Natanegara, PhD

Fanni Natanegara, PhD

  • Senior Director - Statistics
  • Eli Lilly and Company, United States
Telba  Irony, PhD, MS, MSc

Telba Irony, PhD, MS, MSc

  • Senior Scientific Director, Quantitative Sciences
  • Janssen R&D, United States
Through the CID Pilot Program afforded by PDUFA VI, FDA supports the advancement and use of Bayesian clinical trial designs. The Bayesian framework enables continuous learning from various data sources and provides decision-makers with straightforward probabilistic statements. This session will motivate the use of Bayesian approaches in CID by presenting case studies in broad therapeutic areas including rare diseases and highly prevalent chronic disease and discussing success stories, challenges, and opportunities to facilitate drug development.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Articulate principles of Bayesian clinical trial design and analysis
  • Identify situations and opportunities where Bayesian trial designs can be applied in drug development
  • Understand regulatory perspective on the use of Bayesian approaches
  • Understand case examples, the reasons for their successes, and challenges

Speaker(s)

Telba  Irony, PhD, MS, MSc

Speaker

Telba Irony, PhD, MS, MSc

  • Senior Scientific Director, Quantitative Sciences
  • Janssen R&D, United States
Roger J. Lewis, MD, PhD

Speaker

Roger J. Lewis, MD, PhD

  • Professor and Chair, Department of Emergency Medicine
  • Harbor-UCLA Medical Center, United States
Scott M Berry, PhD

Complex Bayesian Primary Analyses in Confirmatory Trials

Scott M Berry, PhD

  • President and Senior Statistical Scientist
  • Berry Consultants LLC, United States
JonDavid  Sparks, PhD

Bayesian Modeling in the CID Pilot Program: Lilly’s Pain Master Protocol

JonDavid Sparks, PhD

  • Principal Research Scientist
  • Eli Lilly and Company , United States
Gianna  McMillan, PhD

Panelist

Gianna McMillan, PhD

  • Bioethics Institute, Associate Director
  • Loyola Marymount University, United States

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Additional Information

Complex Innovative Clinical Trial Designs Resource Kit


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