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Session 5: Study Design Considerations and Innovative Trials Designs
Session Chair(s)
Scott Berry, PHD
President and Senior Statistical Scientist
Berry Consultants LLC, United States
With multiple treatment arms within the same protocol, there is a great potential for innovative trial design features in order to enhance the learnings of the master protocol. Different design features within a platform trial will be discussed including randomization, blinding, treatment comparisons, sharing of controls, longitudinal modeling, and personalizing treatment.
Speaker(s)
Study Design Considerations and Innovative Trials Designs
Roger Lewis, MD, PHD
Berry Consultants, LLC, United States
Senior Medical Scientist
Study Design Considerations and Innovative Trial Designs
Karen Lynn Price, PHD
Eli Lilly and Company, United States
Senior Research Fellow, Statistical Innovation Center/Design Hub
Complex Innovative Designs
Dionne Price, PHD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER