| Abstract: | The QT interval, apart from clinical implications is crucial for safety assessment of new drugs under development. A QTc prolongation of even 10 msec in a study group is a warning signal for a new drug. There are various issues involved in the measurement of the QT interval especially regarding the ending of the T wave and different morphological pattern of T-U complex. The other issue is significant spontaneous variability in the QT interval, resulting in spurious QT prolongation and unnecessary concern.To minimize all these confounding factors, all clinical trials for assessing QT interval prolongation should be randomized and double blinded with appropriate control groups including placebo. ECG measurements should be done by trained readers with electronic calipers at ECG core Lab. ECGs should be compared with multiple baseline values with multiple, time-matched on-treatment values. |
