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Session 3: Technology Advances for Design and Analysis of Complex Innovative Designs Issues
Session Chair(s)
Karen Lynn Price, PhD
Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
The Food and Drug Administration launched the Complex Innovative Trial Design (CID) Pilot Program as a deliverable under the sixth iteration of the Prescription Drug User Fee Amendments. The goal of the program is to facilitate the advancement and use of complex adaptive, Bayesian, or other innovative clinical trial designs requiring simulations to estimate operating characteristics. Given the extent of simulations required and computational intensity associated with the number of simulations needed, it is important that we leverage and advance cutting-edge technology to enable efficient conduct and evaluation of simulations for CIDs. In this session, we will discuss the latest technological advances further enabling CIDs and explore gaps still existing and ways to potentially meet those gaps.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe current state of advanced technology being utilized to further enable CIDs
- Recognize the importance of advancing technology in this space
- Recognize potential gaps in state of technology and opportunities for improving efficiency of conducting and evaluating simulation results
Speaker(s)
Speaker
Paul Schuette, PhD, MA
FDA, United States
Mathematical Statistician, Scientific Computing Coordinator
Leveraging FDA’s Technology Modernization Action Plan to Meet Computing Needs for Complex Innovative Designs
Matilde Kam, PhD
FDA, United States
Associate Director Analytrics and Informatics, OB, OTS, CDER
Speaker
Roger Lewis, MD, PhD
Berry Consultants, LLC, United States
Senior Medical Scientist
Harnessing the Evolving Landscape of R & High-Performance Computing for CID (and Beyond)
Eric Nantz, DrSc, MSc
Eli Lilly and Company, United States
Principal Research Scientist
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