Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives
Track
:
Track 15: Statistical Science and Quantitative Thinking
Program Code:
383
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
Location:
157AB
CHAIR
:
Surya P. Chitra, PhD,MBA (SCHNON), Director, Biostatistics, Endo Health Solutions, United States
Chitra Surya, PhD MBA is an Experienced Biostatistics and Pharmacology prfessional working at PharmaNet Development Group. He has previously worked at AstraZeneca and Merck & Company. His areas of interest are in Clinical operations, Project Mgmt., Corporate Strategy, and Statistical Data Analysis.
SPEAKER
(S):
Yusong Chen, PhD (SPKNON), Endo Health Solutions, United States
Ram Tiwari, PhD (SCHAGY), Associate Director, Office of Biostatistics, OTS, CDER, FDA, United States
His current research interests include developing frequentist and Bayesian methods in clinical trials and pre-and-post market drug safety evaluation.
Ulysses A. Diva, PhD (SPKNON), Principal Statistician, Bioinformatics and Information Sciences, AstraZeneca, United States
Dr. Diva is a Principal Statistician in the Biometrics and Information Sciences group at AstraZeneca. He joined AZ in 2012 with six years of pharma industry experience in designing and analyzing clinical trials, mainly in infectious diseases. He received his PhD from the Univ of Connecticut in 2006.
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.