This white paper presents the Early Precision QT (EPQT) methodology as a validated alternative to traditional Thorough QT studies. It explains how high-precision ECG analysis and concentration-QT modeling can be embedded into early-phase clinical trials to assess cardiac safety earlier and more efficiently. The document summarizes regulatory collaboration with the FDA and industry consortia that led to revisions in ICH E14 guidance. EPQT benefits include reduced late-stage risk, smaller study sizes, faster timelines, and improved decision-making. Real-world validation data demonstrate that EPQT can reliably exclude clinically relevant QT effects, often eliminating the need for dedicated TQT studies.

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