Back to Agenda
Session 4: Bayesian Designs: Continuous Learning and Decision-Making
Session Chair(s)
Fanni Natanegara, PhD
Sr. Director, Global Statistical Sciences - Japan
Eli Lilly and Company, United States
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)
Speaker
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
Speaker
Roger Lewis, MD, PhD
Berry Consultants, LLC, United States
Senior Medical Scientist
Complex Bayesian Primary Analyses in Confirmatory Trials
Scott Berry, PhD
Berry Consultants LLC, United States
President and Senior Statistical Scientist
Bayesian Modeling in the CID Pilot Program: Lilly’s Pain Master Protocol
JonDavid Sparks, PhD
Eli Lilly and Company , United States
Principal Research Scientist
Panelist
Gianna McMillan, PhD
Loyola Marymount University, United States
Bioethics Institute, Associate Director
Have an account?