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Statistical Evaluation of QT/QTc Interval Prolongation

In: Statistical Methods in Biomarker and Early Clinical Development

Author

Listed:
  • Liang Fang

    (MyoKardia Inc.)

  • Winnie Weng

    (Gilead Sciences Inc.)

  • Lu Wang

    (Airbnb Inc.)

  • Xiaoru Wu

    (Facebook Inc.)

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.

Suggested Citation

  • Liang Fang & Winnie Weng & Lu Wang & Xiaoru Wu, 2019. "Statistical Evaluation of QT/QTc Interval Prolongation," Springer Books, in: Liang Fang & Cheng Su (ed.), Statistical Methods in Biomarker and Early Clinical Development, pages 275-299, Springer.
    • Handle: RePEc:spr:sprchp:978-3-030-31503-0_13
    DOI: 10.1007/978-3-030-31503-0_13
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