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Session 2: Decision Making for Master Protocols
Session Chair(s)
Robert A. Beckman, MD
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics
Georgetown University Medical Center, United States
Zoran Antonijevic, MSc
Vice President, Statistical Consulting
Abond CRO Inc., United States
The session will present basic principles of decision analysis for optimization of clinical trials, programs and portfolios with an emphasis on efficiency. Example applications will include standard protocols and portfolios, but will also focus on master protocols. A perspective on this topic from Europe’s EU-Pearl Program will also be presented. Finally, the roles of patients and trial participants as decision makers will be discussed.
Learning Objective : - Understand key concepts related to decision making for clinical trials, master protocols, and portfolios
- Apply selected aspects of decision making with emphasis on master protocols
- Understand Europe’s EU PEARL program and approach to decision making in master protocols
- Define the role of patients as decision makers
Speaker(s)
Decision Making in a Broader Context
Zoran Antonijevic, MSc
Abond CRO Inc., United States
Vice President, Statistical Consulting
Speaker
Robert A. Beckman, MD
Georgetown University Medical Center, United States
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics
Speaker
Martin Posch, PhD
Medical University of Vienna, Austria
Professor
Speaker
Gianna McMillan, PhD
Loyola Marymount University, United States
Bioethics Institute, Associate Director