Abstract:

Following the ICH E14 clinical evaluation guideline [1], the measurement of QT/QTc interval prolongation has become the standard surrogate biomarker for cardiac drug safety assessment and the faith of a drug development. In Thorough QT (TQT) study, a so-called positive control is employed to assess the ability of this study to detect the endpoint of interest, i.e. the QT prolongation by about five milliseconds. In other words the lower bound of the one- sided 95% confidence interval (CI) must be above 0 [ms]. Fully automated detection of ECG fiducial points and mea- surement of the corresponding intervals including QT in- tervals and RR intervals vary between different computer- ized algorithms. In this work we demonstrate the ability and reliability of Hannover ECG System (HES) to as- sess drug effects by detecting QT/QTc prolongation effects that meet the threshold of regulatory concern as mentioned by using THEW database studies namely TQT studies one and two.