Issue 9: Cardiac Safety Assessment In Clinical Trials

Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity development. Sponsors must submit all new chemical entities with systemic exposure to a dedicated thorough QT study (also referred to as TQT study) to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the corrected QT (or, QTc) interval.

In Issue 9, we discuss global regulations, design, and timing of QT assessment, including a case study from a first-in-human clinical trial.