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International Clinical Trials

Navigating ECG Cardiac Safety Requirements

Cardiac safety study requirements apply to almost all drugs in every therapeutic area, not just cardiology. Their aim is to prevent the approval of drugs liable to increase the risk of sudden cardiac death from serious arrhythmias induced by novel agents with unrecognised electrophysiological effects.

These studies matter at every stage of drug development. Even at proof of concept, a biotechnology startup can increase investor interest by demonstrating electrocardiogram (ECG) safety up front. However, since the 1990s, guidance has evolved and uncertainty abounds regarding the correct testing approach. Here, we discuss cardiac safety best practices and how developers can avoid delays from lengthy QT studies as filing time approaches, when overheads are highest.

How Cardiotoxic Drugs Changed the Regulatory Landscape

In the 1990s, adverse event data flagged several drugs as potential cardiac bad actors. These were not obscure medications, but rather drugs with everyday applications. Terfenadine and astemizole were new, non-sedating antihistamines, grepafloxacin was a broad-spectrum antibiotic, and cisapride was a remedy for gastroesophageal reflux. These drugs in overdose, in patients with altered drug kinetics such as the elderly, or in certain drug combinations, caused QT interval prolongation and potentially fatal cardiac arrhythmias. Between 1998 and 2000, manufacturers withdrew these drugs from the market.

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About the authors

Jay W Mason, MD, is a world-renowned cardiac drug safety expert with over 45 years of experience in cardiac care/research, and he has authored hundreds of articles on cardiac repolarisation and the overall diagnosis of ‘torsades de pointes’. A former medical director at Covance Cardiac Safety Services, Jay is Professor of Medicine (Cardiology) at the University of Utah, US, Chief Medical Officer at Spaulding Clinical Research, and an independent consultant in cardiac safety.

Cassandra Erato, CEO at Spaulding Clinical Research, spent the last 12 years at the growing company in positions of increasing responsibility and is an expert in logistics and operations. Spaulding is a full-service CRO providing Phase I drug development and core ECG laboratory services in support of studies throughout all phases of development. Spaulding’s 200-bed clinical pharmacology unit is fully paperless.
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