The Thorough QT/QTc (TQT) study described in ICH Guideline E14 is a rigorous investigation of a noncardiac investigational drug’s proarrhythmic liability. This study is usually conducted relatively late in Phase II of the drug’s clinical development program. In this paper, Dr Salvi and colleagues from Quintiles’ Cardiac Safety Services group presented arguments supporting the initiation of such investigations considerably earlier in the development program. Four years after the paper’s publication, the field of cardiac safety is moving strongly in this direction.
Article September 18, 2015