Sample size calculations in thorough QT studies.

  title={Sample size calculations in thorough QT studies.},
  author={Lu Zhang and Alex Dmitrienko and George Luta},
  journal={Journal of biopharmaceutical statistics},
  volume={18 3},
An analysis of QTc data collected in four thorough QT studies conducted at Eli Lilly and Company was performed to estimate the variability of the QTc interval and to calculate the variance components related to time-to-time, day-to-day variability, etc. The results were used to develop a sample size calculation framework that enables clinical trial researchers to account for key features of their thorough QT studies, including study design (parallel and crossover designs), number of ECG… CONTINUE READING