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A comparison of several methods for analyzing data from thorough QT studies
Hong Tian1, Wenqian Qiao, Jaya Natarajan
1Johnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey, USA. htian@its.jnj.com
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%.
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