An efficient crossover design for thorough QT studies

Arne Ring, Beate Walter, Anna Larbalestier & Dennis Chanter
Background: Thorough QT studies are typically a requirement of the clinical development program for new investigational drugs. These studies are a major cost factor in early development. The objectives of a typical thorough QT study (TQT) are to demonstrate (a) that therapeutic and supra-therapeutic doses of a new investigational drug do not prolong the ECG QT interval compared to placebo and (b) that an active control does show QT prolongation compared to placebo. In recent...