Mean or Time-matched? The Choices of Baseline QTc for Parallel TQT Studies
View Presentation View Presentation
*Qianyu Dang, FDA 

Keywords: TQT Study with parallel designs, non-parametric,

The purpose of this project is to evaluate whether the mean or time-matched baseline QTc should be used in statistical analysis in thorough QTc studies with parallel designs. We analysis the baseline profile in QTcF for all treatment groups based on 25 submitted parallel studies with 4787 individuals. It is indicated that 24-hour QTc profile is not flat and using the mean as baseline could have impact on both mean and the variance of ddQTc.