Sample size calculation for thorough QT/QTc study considering various factors related to multiple time points
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Updated: Jun 14, 2026

Electrophysiological Analysis of human Pluripotent Stem Cell-derived Cardiomyocytes (hPSC-CMs) Using Multi-electrode Arrays (MEAs)
Published on: May 12, 2017
Zhaoling Meng1, Robert Kringle, Xun Chen
1Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA. zhaoling.meng@sanofi-aventis.com
Abstract:
The sample size requirement in a thorough QT/QTc study is discussed under a balanced parallel or crossover study design. First, we explore the impacts of various factors on the study power, including the mean effect profile across time and correlation among time points. Then we estimate the variability parameters needed based on multiple historical studies. Different baseline usage is illustrated to have a significant impact on the analysis variability in the parallel studies. Finally, the sample size calculations and recommendations are given for demonstrating a "negative" drug effect and the study assay sensitivity, respectively.
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