A Comparison of Several Methods For Analyzing Data from Thorough QT Studies

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%.

Key Words:

• Intersection union test
• Power
• Thorough QT

Notes

Note. Based on 5000 simulation runs.

Note. Based on 5000 simulation runs.