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Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives
Session Chair(s)
Surya P. Chitra
Consultant, Biostatistics and Statistical Programming
Savio Group Analytics, United States
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 : 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.
Speaker(s)
Challenges Related to Noninferiority Tests: An Overview
Yusong Chen, PhD
Endo Health Solutions, United States
Senior Director, Biostatistics
Noninferiority Margin Determination Using Dirichlet Process and Power Priors
Ram Tiwari, PhD, MS
Bristol Myres Squibb , United States
Head of Statistical Methodology
Practical Experiences with Design and Analysis of Noninferiority Clinical Trials in Infectious Diseases
Ulysses A Diva, PhD
AstraZeneca, United States
Principal Statistician, Bioinformatics and Information Sciences
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