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.


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