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Tuesday, June 29 • 2:00pm - 3:00pm
#249 SL: Innovative Statistical Strategies and Designs in Oncology Drug Development

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-584-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Xiaoyun (Nicole) Li, PhD


Opportunities and Challenges of Master Protocol Trials
Xiaoyun (Nicole) Li, PhD

Biomarker Enrichment Design: An Effective Approach that Wins a Regulatory Approval for Oncology Trials
Weidong Zhang, PhD

Yuan-Li Shen, DrPH

Leverage of External Evidence in Drug Development and Regulatory Decision Making in Oncology
Rong Liu, PhD, MS


Xiaoyun (Nicole) Li

Senior Principal Scientist, Merck & Co., Inc., United States
avatar for Rong Liu

Rong Liu

Director of Biostatistics, Oncology, Bristol-Myers Squibb Company, United States
avatar for Weidong Zhang

Weidong Zhang

Vice President, Head of Biostatistics and Programming, Jounce Therapeutics, United States
Dr. Weidong Zhang is currently the Vice President, Biostatistics and Programming at Jounce Therapeutics. He oversees biostatistics and programming to support end-to-end clinical development in immuno-oncology regarding study design, execution and medical affairs. Prior to Jounce... Read More →
avatar for Yuan-Li Shen

Yuan-Li Shen

Deputy Division Director (Acting), Division of Biometrics V, OB, OTS, CDER, FDA, United States
Yuan-Li is the acting Associate Director in Division of Biometrics V, Office of Biostatistics, Office of Translational Science, CDER, FDA. The teams that she is associated with support all statistical aspects of regulatory submissions in Gastrointestinal, Lung/Head and Neck, Neuro-oncology/Rare... Read More →

Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum
  • Beginner Advanced
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Innovative Trial Design
  • Featured Topics Innovative Trial Design
  • Tags Forum