JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 274
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #310121
Title: Statistical Issues of a Thorough QT/QTc Study
Author(s): Joanne Zhang*+
Companies: Food and Drug Administration
Address: 2928 Marlow Farm Terr, Silver Spring, MD, 20904,
Keywords: thorough QT/QT study ; statistical testing ; assay sensitivity
Abstract:

QT/QTc prolongation may cause ventricular arrhythmias including ventricular fibrillation and Torsade de Pointes, which can be fatal; therefore, the current ICH E14 Guidance requests all sponsors submitting new drug applications to conduct at least one thorough QT/QTc study, normally early in clinical development after some knowledge of pharmacokinetics of the drug. It is recommended that a double blinded, randomized, crossover or parallel QT/QTc study should be considered in healthy volunteers (some exceptions). The goal of a 'thorough QT/QTc study' (TQT) is to test if the mean QT/QTc difference of the drug and placebo is no greater than 10 ms (non-inferiority margin). If yes, we might conclude that the drug does not have the QT prolongation effect. In this presentation, I will address some statistical issues in terms of the design and analysis of a TQT study.

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Revised September, 2007