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Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Session Chair(s)

Representative Invited
FDA, United States
In this session, speakers will share their insight with case studies to demonstrate how the challenges have been addressed and introduce new methods for designing appropriate wining criteria for composite endpoint in small-sized clinical trials.
Learning Objective : Understand the pros/cons and challenges in designing clinical trials with composite endpoints; Learn advanced methods and strategies for analyzing composite endpoints, including the impact of winning criteria and analysis methods via win ratio, win proportion and win scores; Apply different win ratio methods by scenarios and interpret results from real case examples of small-size.
Speaker(s)

Weighted Win Score Ratio – A Generalization of Win-Ratio Approach for Composite Endpoints with Continuous Components
Qian Tang, PhD
University of Iowa, United States

Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials
Jialu Wang, PhD
Vertex Pharmaceuticals, United States
Statistician
Application of win statistics in non-malignant hematology
Wenquan Wang, PhD
Pfizer, United States
Senior Director
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