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Abstract:
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Eli Lilly and Company has recently conducted four thorough QT studies. A meta-analysis of these trials was performed to estimate the variability of QT interval and calculate variance components related to minute-to-minute, day-to-day variability, etc. The obtained results were used to develop a series of sample size calculation formulas that be utilized in powering future thorough QT studies. The proposed sample size calculation approach enables clinical trial researchers to account for various features of their thorough QT study, including study design (parallel and cross-over designs), single-, double-delta methods, patient population (male and/or female subjects) and the number of ECG replicates.
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