Statistical Analyses Discussed in ICH

The statistical details of the intersection-union and union-intersection tests used in the analysis of QTc data following the completion of a TQT study were provided in Chap. 5 since we believe that readers interested in that level of detail should have access to it within this book. That said, our discussions in this chapter are couched in more simple nomenclature. 

ICH E14 noted that The QT/QTc interval data should be presented both as analyses of central tendency (e.g., means, medians) and categorical analyses. Both can provide relevant information on clinical risk assessment (ICH 2005b). 

Categorical analyses, which are descriptive in nature and the simpler of the two sets of analyses, are discussed first. 

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