Key result
Designing a thorough QT/QTc study requires careful consideration of QT interval variations, risk factors, pharmacokinetic-pharmacodynamic relationships, and appropriate sample size determination.
Provides methodological considerations for designing thorough QT/QTc studies to evaluate drug-induced QT prolongation.
Guides rigorous QT study design for drug safety trials; leaves open validation across agents and populations.
The ‘thorough QT/QTc study’ has a critical role in evaluating QT/QTc interval prolongation of a drug. In designing the ‘thorough QT/QTc study' it is important to consider cause of variation of QT intervals and risk factors of QT prolongation, such as reliability of QT interval measurement, diurnal variation, pharmacokinetics, pharmacokinetics-pharmacodynamics relationship, age, gender, electrolyte abnormalities, concomitant drugs, concomitant diseases, etc. Choice of parallel or cross-over design and sample size determination are also discussed.
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Yasushi Orihashi (2008) conducted a review in QT/QTc interval prolongation. Thorough QT/QTc study design was evaluated. Designing a thorough QT/QTc study requires careful consideration of QT interval variations, risk factors, pharmacokinetic-pharmacodynamic relationships, and appropriate sample size determination.
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