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Centralising ECGs

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.


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Dr Jeffrey S Litwin is a board certified Internist and Cardiologist. He left his cardiology practice in 1988 to serve as Director, Medical Affairs at Wyeth-Ayerst Laboratories. Jeffrey has been providing consultative support to the pharmaceutical industry for the design and conduct of cardiac safety trials and to the device industry for the design of ECG and Holter technologies for over 15 years. He is currently an Executive Vice President and the Chief Medical Officer for eResearchTechnology ERT), which he joined in July, 2000.

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