Statistical Evaluation of QT/QTc Interval Prolongation

Liang Fang (), Winnie Weng, Lu Wang and Xiaoru Wu
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Liang Fang: MyoKardia Inc.
Winnie Weng: Gilead Sciences Inc.
Lu Wang: Airbnb Inc.
Xiaoru Wu: Facebook Inc.

A chapter in Statistical Methods in Biomarker and Early Clinical Development, 2019, pp 275-299 from Springer

Abstract: Abstract QT interval prolongation is a measure of delayed cardiac repolarization that could lead to the development of cardiac arrhythmias, namely torsade de pointes (TdP). TdP is a serious toxicity associated with some non-antiarrhymic drugs. The magnitude of QT prolongation has been used as an imperfect surrogate for TdP. In this chapter, we review statistical considerations for the evaluation of QT/QTc interval prolongation. Regulatory history and scientific background are provided in Sect. 1. Section 2 is devoted to the design and analysis of thorough QT study (i.e., TQT) as a way of evaluating QT prolongation risk, as recommended by ICH E14. In Sect. 3, an alternative to TQT study, concentration–QTc (i.e., CQT) analysis is discussed. The CQT approach has been adopted by ICH E14 R3 as an acceptable alternative to TQT for the evaluation of QT prolongation risk.

Date: 2019
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DOI: 10.1007/978-3-030-31503-0_13

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