Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 26, 4:00PM - 5:30PM

Session Number:
383

Room Number:
157AB

Level:
Intermediate

Type:
Session

Title:
Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives

Chair(s):
Surya P. Chitra, PhD,MBA
Director, Biostatistics
Endo Health Solutions, United States

Description:
Increasing trends in conducting noninferiority trials in drug development will continue as more drugs are approved. Although this trend will make interpretation of trial results more challenging, it can provide opportunities for new outcomes for patients.

Learning Objective(s):
Identify the crucial role of noninferiority trials in oncology drug development; Discuss how to manage risk with noninferiority/superiority trials in oncology; Evaluate strategies for implementing noninferiority trials; Identify the challenges and opportunities with noninferiority trials.

Presentation(s) & Speaker(s):
Challenges Related to Noninferiority Tests: An Overview
Yusong Chen, PhD
Senior Director, Biostatistics
Endo Health Solutions, United States

Noninferiority Margin Determination Using Dirichlet Process and Power Priors
Ram Tiwari, PhD
Associate Director, Office of Biostatistics, OTS, CDER
FDA, United States

Practical Experiences with Design and Analysis of Noninferiority Clinical Trials in Infectious Diseases
Ulysses A Diva, PhD
Principal Statistician, Bioinformatics and Information Sciences
AstraZeneca, United States