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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)
Paul Schuette, PHD, MA
Mathematical Statistician, Scientific Computing Coordinator, FDA, United States
Speaker
Matilde Kam, PHD
Associate Director Analytrics and Informatics, OB, OTS, CDER, FDA, United States
Leveraging FDA’s Technology Modernization Action Plan to Meet Computing Needs for Complex Innovative Designs
Roger Lewis, MD, PHD
Senior Medical Scientist, Berry Consultants, LLC, United States
Speaker
Eric Nantz, DRSC, MSC
Principal Research Scientist, Eli Lilly and Company, United States
Harnessing the Evolving Landscape of R & High-Performance Computing for CID (and Beyond)
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