This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
468
|
Type:
|
Contributed
|
Date/Time:
|
Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #306863 |
Title:
|
Comparison of Statistical Models Adjusting for Baseline in the Analysis of Thorough QT/QTc Studies
|
Author(s):
|
Guowen (Gordon) Sun*+ and Hui Quan
|
Companies:
|
sanofi-aventis and sanofi-aventis
|
Address:
|
Mail Stop: BX2-403A, Bridgewater, NJ, 08807,
|
Keywords:
|
statistical power ;
type I error ;
time-matched baseline ;
day-averaged baseline ;
parallel studies
|
Abstract:
|
For thorough QT/QTc studies, definition of baseline for adjusting QTc values remains an important research topic. The ICH E14 recommends the use of time-matched baseline while others recommend other baseline definitions including day-averaged baseline. The debate focuses on the analysis efficiency when measurements are made at multiple time-points. Here, we consider six models including models based on time-matched baseline and day-averaged baseline. We derive the explicit covariances for each of the models and compare their power under various conditions. Simulation results are provided for by time-point and repeated measures mixed models. We conclude that type I error rates are controlled in all cases. However, one type of model outperforms the others on statistical power under certain conditions. We will recommend a model based on our derivations and simulations.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2010 program
|
2010 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.