JSM 2005 - Toronto

Abstract #303468

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 408
Type: Luncheons
Date/Time: Wednesday, August 10, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303468
Title: Statistical Issues Related to the FDA Draft Guidance 'The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Nonantiarrhythmic Drugs'
Author(s): Lisa Hickey*+
Companies: Merck Research Laboratories
Address: 10 Sentry Parkway, Blue Bell, PA, 19422, United States
Keywords: QT ; clinical trials ; study design
Abstract:

The E14 draft guidance will require a thorough QT/QTc study for most future drug programs. While the guidance suggests approaches to rule out potential QT/QTc issues for a compound, there are statistical issues that should be explored. Issues that may be discussed include how to handle multiplicity, formulating the hypothesis, machine-read versus hand-read ECGs, replicates, timepoints, heart-rate adjustments, and appropriate baseline measurements.

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Revised March 2005