A Statistical Assessment of QT Data Following Placebo and Moxifloxacin Dosing in Thorough QT Studies

  title={A Statistical Assessment of QT Data Following Placebo and Moxifloxacin Dosing in Thorough QT Studies},
  author={Anastasia Stylianou and James H. Roger and Kimberley Stephens},
  journal={Journal of Biopharmaceutical Statistics},
  pages={502 - 516}
The ICH guidelines indicate that a single “thorough QT study” should be conducted to evaluate the effects of new drugs on cardiac repolarization. A positive control, such as moxifloxacin, is required to be assessed as part of the thorough QT study to validate the assay sensitivity of each study. In order to better understand the effect of moxifloxacin, a meta-analysis of nine thorough QT studies has been undertaken to assess the overall moxifloxacin effect. The data was analyzed using a… 

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Methods of analysis and statistical inference are developed for the QTc end points considered and consideration of the statistical properties of various end points proposed for measurement is considered.

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  • 2005