A comparison of several methods for analyzing data from thorough QT studies.
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%.
Tian
Hong
H
Johnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey, USA. htian@its.jnj.com
Qiao
Wenqian
W
Natarajan
Jaya
J
D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000175:diagnosis / Q000503:physiopathology; D002940:Circadian Rhythm; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D004562:Electrocardiography / Q000706:statistics & numerical data; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D015233:Models, Statistical; D013997:Time Factors