Statistical Analysis for QT Data
*Phillip Dinh, FDA 


Assessment of QT effects has been becoming a routine in the drug development process. However, the design and analysis of QT studies are still facing some challenges. Topics for discussion include: 1) what is the appropriate QT endpoint? 2) how to evaluate assay sensitivity? 3) what designs are appropriate for a QT study where the drug has to be titrated over many days? 4) How to deal with dropout in a QT study? 5) How to reduce variability?