戻る Agenda
Session 2: Complex Innovative Designs
Session Chair(s)
Min Lin, MD, PhD
Statistical Science Director
Astrazeneca, United States
Amy Xia, PhD
Vice President, Center for Design and Analysis
Amgen Inc., United States
Both the 21st Century Cures Act and the PDUFA VI legislations emphasize on complex innovative designs, which require simulations to understand the design operating characteristics, statistical properties, and operational features. This session will review and discuss the issues related to any complex trial design that we need to simulate the trial to understand its full behavior. Additionally, it will discuss analyses that are complex enough so that we likely need simulation for deeper understanding of the models. Examples of complex analyses include using hierarchical analyses and historical data will be given. A group of speakers and panelists will discuss opportunities and challenges relative to complex innovative designs and analyses in medical product development.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the role of simulation in complex innovative designs and analyses
- Discuss case studies in complex innovative designs and analyses
- Describe challenges and opportunities in complex innovative designs and analyses
Speaker(s)
Simulations for Clinical Trial Operating Characteristics
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
Complex Clinical Trials: Design and Analysis
Scott Berry, PhD
Berry Consultants LLC, United States
President and Senior Statistical Scientist
Panelist
Brian Hobbs, PhD
The University of Texas at Austin Dell Medical School, United States
Associate Professor
Panelist
Karen Lynn Price, PhD
Eli Lilly and Company, United States
Senior Research Fellow, Statistical Innovation Center/Design Hub
Panelist
Estelle Russek-Cohen, PhD
FDA, United States
Senior Advisor, Office of Biostat