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Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives
Session Chair(s)
Satrajit Roychoudhury, PHD
Executive Director, Statistical Research and Innovation
Pfizer, United States
The session explores the integration of external data in clinical trials to enhance efficiency, reduce sample sizes, and shorten timelines. It covers methodological advances, regulatory perspectives, and best practices for using external controls.
Learning Objective : Identify the nuances while integrating external data in trial design and analysis; Evaluate regulatory requirements and perspectives; Discuss the possibility of external control trial in their organization.
Speaker(s)
Panelist
Xiaofei Wang
Duke University Medical Center, United States
Professor, Biostatistics & Bioinformatics
Panelist
Scott Berry, PHD
Berry Consultants LLC, United States
President and Senior Statistical Scientist
Panelist
Pralay Mukhopadhyay, PHD
GSK, United States
Vice President, Medicines Development Leader, Oncology R&D
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