Assessment of QT Interval in Clinical Drug Development


Dr. Alex Dmitrienko (Mediana Inc).

Half-day course

Total duration: 2 hours 26 minutes.

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Assessment of cardiac liability of new compounds, particularly with respect to life threatening ventricular tachydysrhythmias, e.g., Torsades de Pointes (TdP), has become a critical component of drug development programs. QTc prolongation is commonly used as a surrogate biomarker for an increased risk of TdP. The International Conference on Harmonization (ICH) published a guidance document (ICH E14) to describe strategies for the evaluation of cardiac safety of drugs in clinical development. This document introduced a new approach to the assessment of proarrhythmic potential of new drugs (thorough QT study). Thorough QT studies are now required for virtually all non-cardiac drugs with systemic bioavailability. This course focuses on key statistical and practical issues arising in the assessment of QT interval prolongation in clinical trials with emphasis on the design and analysis of thorough QT studies. The course reviews multiple examples from recently conducted thorough QT/QTc studies and discusses regulatory considerations in this area of clinical drug development.


Topics covered in this Instant Short Course:

  • Introduction. Duration: 10 minutes.
  • Module A. Background information on QTc interval. Duration: 12 minutes.
  • Module B. Design considerations: Control of QTc variability, Study design, Definition of QTc treatment difference, Sample size calculations, ECG acquisition schedule. Duration: 1 hour.
  • Module C. Analysis considerations: Peak QTc effect and reverse multiplicity, Assay sensitivity analysis, Classification of QTc effects, QT correction, QTc-exposure analysis. Duration: 1 hour 4 minutes.

Supplementary material

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