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Cardiac safety has become the number one reason for drug withdrawals and labelling changes during the past several years. This has resulted in greater regulatory scrutiny for all new compounds and greater concern among pharmaceutical companies in regard to the potential effect of their compounds on cardiac safety. One of the outcomes of this focus was the ICH E14 document, which provided guidance on the conduct of a dedicated ECG study which many term the ‘thorough QT (TQT) trial’ (1). These trials are generally conducted after proof of concept has been completed and employ digital and centralised ECGs as described in E14. However, although almost all TQT trials are centralised, only approximately 20 to 25 per cent of all other clinical research (Phases I-IV) trials use centralised ECG analyses. |
