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Innovative Statistical Strategies and Designs in Oncology Drug Development
Session Chair(s)
Xiaoyun (Nicole) Li, PHD
Senior Principal Scientist, Merck & Co., Inc., United States
This session will cover three types of trials: (1) master protocols; (2) biomarker enrichment trials; and (3) trials leveraging RWD. Opportunities and challenges rising in design and execution of these trials will be shared and discussed.
Learning Objective : Recognize different types of the innovative designs used in oncology drug development; Discuss common challenges in the design, analysis, and execution of clinical innovative trials; Evaluate different strategies and propose appropriate options for their studies.
Speaker(s)
Xiaoyun (Nicole) Li, PHD
Senior Principal Scientist, Merck & Co., Inc., United States
Opportunities and Challenges of Master Protocol Trials
Weidong Zhang, PHD
Vice President, Head of Biometrics , Sana Biotechnology, United States
Biomarker Enrichment Design: An Effective Approach that Wins a Regulatory Approval for Oncology Trials
Yuan-Li Shen, DrPH
Division Director, Division of Biometrics IX, OB, OTS, CDER, FDA, United States
Discussant
Rong Liu, PHD, MS
Director of Biostatistics, Oncology, Bristol-Myers Squibb Company, United States
Leverage of External Evidence in Drug Development and Regulatory Decision Making in Oncology
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