|
Activity Number:
|
404
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Wednesday, August 6, 2008 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #300520 |
|
Title:
|
A Multivariate Approach to Sample Size Calculations for Thorough QT Studies
|
|
Author(s):
|
Sharon C. Murray*+ and Suraj P. Anand and Gary G. Koch
|
|
Companies:
|
GlaxoSmithKline and North Carolina State University and The University of North Carolina at Chapel Hill
|
|
Address:
|
114 Springdale Way, Chapel Hill, NC, 27517,
|
|
Keywords:
|
QTc ; Monte Carlo simulation ; Thorough QT Study ; correlated measurements
|
|
Abstract:
|
Thorough QT (TQT) studies are routinely conducted by pharmaceutical companies to satisfy the requirements of the ICH E14 Guidance. The cost involved in running a TQT study is substantial and sample size calculations play an important role in ensuring a small but adequately powered TQT study. In a TQT study, multiple observations are collected over time and it is reasonable to assume that observations are correlated and follow the multivariate normal distribution. We use Monte Carlo simulation to determine sample size varying the true maximum difference, the pattern of true differences over time, and the correlation between observations assuming a compound symmetric model for both the parallel and crossover designs. For the crossover design we also consider a variance components model in which correlation is greater for observations taken during the same period.
|
