The ratification of the E14 guideline in May 2005 by the ICH
steering committee presented the first major safety guidance
adopted by a global regulatory body. However, this landmark
regulation, appropriately for its time, focused on only one
aspect of drug-induced cardiotoxicity – QT prolongation
and pro-arrhythmia. Boaz Mendzelevski, MD at Cardiac
Safety Consultants Ltd, explains how the emerging field of
oncology drug-induced cardiovascular toxicity, also known
as ‘cardio-oncology’ (CO), expanded the boundaries of the
current cardiac safety model beyond QT prolongation and proarrhythmia,
to include all forms of drug-induced cardiovascular
toxicities.