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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)
Roger Lewis, MD, PhD
Senior Medical Scientist, Berry Consultants, LLC, United States
Study Design Considerations and Innovative Trials Designs
Karen Lynn Price, PhD
Senior Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company, United States
Study Design Considerations and Innovative Trial Designs
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Complex Innovative Designs
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