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DIA 2021 Global Annual Meeting


Innovative Statistical Strategies and Designs in Oncology Drug Development

Session Chair(s)

Xiaoyun (Nicole)  Li, PhD

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

Opportunities and Challenges of Master Protocol Trials

Xiaoyun (Nicole) Li, PhD

  • Senior Principal Scientist
  • Merck & Co., Inc., United States
Weidong  Zhang, PhD

Biomarker Enrichment Design: An Effective Approach that Wins a Regulatory Approval for Oncology Trials

Weidong Zhang, PhD

  • Vice President, Head of Biostatistics and Programming
  • Jounce Therapeutics, United States
Yuan-Li  Shen, DrPH

Discussant

Yuan-Li Shen, DrPH

  • Deputy Division Director (Acting), Division of Biometrics V, OB, OTS, CDER
  • FDA, United States
Rong  Liu, PhD, MS

Leverage of External Evidence in Drug Development and Regulatory Decision Making in Oncology

Rong Liu, PhD, MS

  • Director of Biostatistics, Oncology
  • Bristol-Myers Squibb Company, United States