Professor Balakrishna Hosmane : Non-Inferiority Testing in Thorough QT/QTc Studies

Posted by , part of the Statistics and Data Science Seminar.

At

Sept. 28, 2005, 3 p.m.

In

SEO 512

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.

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