Why the study?
Despite the T wave affecting QT interval measurement and subject management, recognition and understanding of different T wave configurations remain incomplete and have not been formally incorporated into pharmaceutical research.
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Design
Comprehensive review
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Supports T-wave assessment in trials for safety monitoring; leaves open prospective validation before guideline integration.
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.
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Lester et al. (2025) studied this question.
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