Why the study?
Do semiautomated methods for QT measurement reduce the required sample size compared to fully automated methods in a thorough QT/QTc study?
Population
62 participants in a thorough QT/QTc study
Comparison
Semiautomated methods for QT measurement vs Fully automated method for QT measurement
Authors
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Enables smaller thorough QT studies with semiautomated analysis; extends RCT evidence for efficient ECG methods in cardiac safety trials.
Do semiautomated methods for QT measurement reduce the required sample size compared to fully automated methods in a thorough QT/QTc study?
Semiautomated QT measurement methods exhibit less variability than fully automated methods, allowing for smaller sample sizes in thorough QT/QTc studies.
Tyl et al. (2009) studied this question.
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