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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)
Opportunities and Challenges of Master Protocol Trials
Xiaoyun (Nicole) Li, PHD
Merck & Co., Inc., United States
Senior Principal Scientist
Biomarker Enrichment Design: An Effective Approach that Wins a Regulatory Approval for Oncology Trials
Weidong Zhang, PHD
Sana Biotechnology, United States
Vice President, Head of Biometrics
Discussant
Yuan-Li Shen, DrPH
FDA, United States
Division Director, Division of Biometrics IX, OB, OTS, CDER
Leverage of External Evidence in Drug Development and Regulatory Decision Making in Oncology
Rong Liu, PHD, MS
Bristol-Myers Squibb Company, United States
Director of Biostatistics, Oncology