Key result
Linear concentration-QTc models demonstrated adequate sensitivity and specificity, yielding less than +1 ms mean bias in ΔΔQTcmax prediction and >80% power to exclude 10 ms.
Why the study?
Do linear C-QTc models provide adequate sensitivity and specificity for assessing QTc interval in clinical studies?
Population
Simulated clinical QT studies (crossover and parallel designs with 12 to 60 subjects per treatment)
Authors
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May enable reliable QTc assessment in early-phase studies; leaves open validation in confirmatory trials.
Do linear C-QTc models provide adequate sensitivity and specificity for assessing QTc interval in clinical studies?
Linear C-QTc models incorporating time- and treatment-specific terms offer robust, unbiased predictions for QTc interval assessment in early-phase clinical studies.
Garnett et al. (2016) studied QTc interval assessment. Linear Concentration-QTc (C-QTc) models was evaluated on False negative rate, mean bias in ΔΔQTcmax prediction, and power to exclude 10 ms. Linear concentration-QTc models demonstrated adequate sensitivity and specificity, yielding less than +1 ms mean bias in ΔΔQTcmax prediction and >80% power to exclude 10 ms.
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