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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)
John Scott, PHD, MA
Division Director, Office of Biostatistics, CBER, FDA, United States
Simulations for Clinical Trial Operating Characteristics
Scott Berry, PHD
President and Senior Statistical Scientist, Berry Consultants LLC, United States
Complex Clinical Trials: Design and Analysis
Brian Hobbs, PHD
Associate Professor, The University of Texas at Austin Dell Medical School, United States
Panelist
Karen Lynn Price, PHD
Senior Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company, United States
Panelist
Estelle Russek-Cohen, PHD
Senior Advisor, Office of Biostat, FDA, United States
Panelist