How to Obtain and Analyze Electrocardiograms in Clinical Trials

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Abstract
Prolongation of the QTc interval on the ECG associated with reports of sudden death produced by noncardiac drugs has focused the attention of regulatory authorities on ECG findings from clinical drug development programs. During clinical testing, the nonrigorous, site‐specific, and largely uncontrolled methods for performing and analyzing ECGs that is currently practiced should now be reconsidered. Current methods may miss important cardiac electrophysiological effects of new drugs as well as produce false‐positive ECG findings that are artifactual and the result of the methods used. The use of a core ECG laboratory that has cardiovascular expertise, state‐of‐the‐art information management technologies, and ECG reading systems that are scientifically validated, quality assured, and precise can cost effectively manage a development program's entire ECG safety program. A.N.E. 1999;4(4):425–433