Surfing the T Wave: A Primer on ECG T Wave Morphologies Encountered in Clinical Trials and Impact on the QT Interval and Patient Safety.

Electrocardiogram (ECG) interpretation and measurement is an essential aspect of patient safety and pharmacovigilance in clinical trials. Changes in the T wave segment of an ECG can provide both diagnostic and prognostic information and may be affected by a variety of intrinsic and extrinsic factors related to drug administration. To add, regulators in their guidance encourage sponsors to provide analysis on treatment-emergent T wave morphology changes when submitting clinical study reports. Despite the T wave representing an important element of an ECG and impacting QT interval measurement, there is often a lack of recognition and incomplete understanding of the different T wave configurations that would affect subject management. Moreover, this topic has not been formally incorporated in pharmaceutical research. Therefore, this comprehensive review aims to profile normal and abnormal T wave morphologies that scientists and principal investigators might encounter during study conduct that would influence patient management and safety. This includes commentary on T wave pathophysiology, prognostic information, and short- and long-term management strategies when T wave abnormalities are present.