A comparison of several methods for analyzing data from thorough QT studies

J Biopharm Stat. 2010 May;20(3):632-40. doi: 10.1080/10543400903582034.

Abstract

Currently, the intersection-union test (IUT) is the standard method of analysis of the data from a thorough QT (TQT) study. In this current work, we compared the methods proposed in three recent publications (Boos et al., 2007; Cheng et al., 2008; Eaton et al., 2006) to IUT using a simulation study. The methods proposed by Cheng and Eaton did not produce a considerable improvement over IUT in the power and size of the test. The power of the Boos et al. method was a substantial improvement over IUT, but the size of the test was found to be greater than 5%.

Publication types

  • Comparative Study

MeSH terms

  • Arrhythmias, Cardiac / chemically induced*
  • Arrhythmias, Cardiac / diagnosis
  • Arrhythmias, Cardiac / physiopathology
  • Circadian Rhythm
  • Clinical Trials as Topic / statistics & numerical data*
  • Computer Simulation
  • Data Interpretation, Statistical
  • Electrocardiography / statistics & numerical data
  • Heart Rate / drug effects*
  • Humans
  • Models, Statistical*
  • Time Factors