Statistics and Data Science Seminar
Professor Balakrishna Hosmane
Northern Illinois University (Director of Statistical Consulting Services, Division of Statistics)
Non-Inferiority Testing in Thorough QT/QTc Studies
Abstract: Evaluation of new drugs for unwanted effects on electrical properties of the
heart is receiving heightened attention from pharmaceutical companies and
regulatory agencies. This attention arises from recent scientific research that
links drug effects in cellular ion channels to changes in electrical
characteristics of the electrocardiogram (ECG) that predict clinically important
cardiac arrhythmias. An assessment of non-inferiority of the higher dose to
placebo is performed in four-period cross-over study as well as four-group
parallel study by the union- intersection test within the framework of a linear
mixed effects analysis. For the purposes of planning such a study, the joint
distribution of the estimate of the difference in means of high dose of
investigational drug and the placebo was derived. The power of thorough QT/QTc
study evaluated using the joint distribution and the simulation study were quite
close.
Drinks, cakes, ... will be provided.
Wednesday September 28, 2005 at 3:00 PM in SEO 512