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Current Regulatory Authority Stance on Electrocardiogram Data in Clinical Trials

Historical Perspective

Electrocardiograms (ECGs) have been recorded in clinical trials for years and the results have been used to include/exclude subjects and to determine whether or not a test compound has any cardiovascular effects. Ordinarily, in non-cardiovascular indications the emphasis on ECG data was limited to safety analysis in early Phase I trials only. Holter monitors (continuous 24 or 48 hour amb

ulatory monitors) or telemetry systems were commonly used to screen healthy volunteers in early phase studies and to monitor any potential cardiovascular side effects following drug administration.

In the 1980s however, indications arose that non-cardiovascular drugs may be having unwanted side effects on the repolarisation of the myocardium. The physical evidence of this was a prolongation of the QT interval that, in some cases, led to a potentially life-threatening arrhythmia called 'torsade de pointes' (see Figures 1 and 2). This problem led to the high profile withdrawal of a number of licensed drugs (for example cisapride, grapefloxacin, terfenadine) and firmly focused the industry's attention on the QT interval.


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By Dr Sue Miles, Chief Executive of Quantum Research

Dr Sue Miles is the Chief Executive of Quantum Research, which was founded in 2003 following a merger between PDS Research and Hertford Medical International within the Ferraris Group of Companies. She joined Hertford Medical in 1996 as Clinical Services Manager and became Chief Executive in 1998. Sue's scientific background helps her to analyse and focus the company's activities productively and effectively. Sue is responsible for the overall running of the company and maintains an active involvement in every aspect of the business. She holds a MA (Hons) in Natural Sciences from Newnham College, Cambridge and a PhD from the Faculty of Medicine at Edinburgh University.

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Dr Sue Miles
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