Careful assessment of QT and other ECG parameters in clinical trials is essential for ensuring cardiac safety. Therefore, small molecule compounds in development must undergo rigorous testing for their potential to prolong the QT interval on ECG as defined in the ICH E14 Guidance. The historical approach, Thorough QT (TQT) conducted in late phase, increases the risk of losing time and money.
ECGs collected and analyzed during routine early phase studies using EPQT can provide reliable cardiac safety information that replaces the data historically derived from high-cost TQT studies.
Obtain precise, actionable data earlier in the drug development process and proceed with confidence.
Demonstrate QT effect in Phase I when assessments can be significantly less expensive than in late phase.
In either case this result is an important component of the totality of evidence assessment of the risk of QT prolongation. The overall assessment of risk of QT prolongation includes nonclinical data, the time course of QT prolongation, the magnitude of QT prolongation, categorical analyses of outliers, and certain adverse events in patients that can signal potential proarrhythmic effects.