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The Heart of the Matter

 

Cardiac safety is the primary reason for drug withdrawals and labelling challenges. As a result, industry regulations are under increased scrutiny. Biopharmaceutical, CROs and medical device companies are constantly tasked to provide quality electrocardiogram (ECG) data that are critical to ensuring the most accurate assessment of a new drug’s cardiac effect. ECG data are used to assess the effect of investigational drugs on the electrical functions of the heart. Centralising the process of collection and standardisation of quality ECG data not only reduces inconsistencies that may occur from site to site, but also alleviates laboratory workloads. This article discusses the regulatory requirements in relation to ECGs and highlights the benefits of a centralised versus a decentralised approach.

LEGISLATIVE OVERVIEW

Recent concerns over the cardiac effects of new pharmaceutical products have triggered greater regulatory scrutiny for all new compounds and final drugs prior to reaching the marketplace. While there is no legislative mandate in relation to ECG assessment across all clinical trials, the requirement to conduct a thorough ECG trial (TET) for new compounds has been mandated by the US Food and Drug Administration (FDA) with limited exceptions. This is a result of the introduction of the ICH E14 guideline, which was developed to assess QT/QTc prolongation in new drugs to determine cardiac safety risks.

The ICH E14 guideline recommends that a TET should be performed and if any cardiac safety concerns are raised, Phase III trials will require more robust or intense ECG collection. Unlike many other clinical trials, the TET typically uses a centralised system, which has proven to greatly improve the accuracy and reliability of ECG data in clinical trials. This centralised approach uses standardised digital ECG machines for collection and a centralised high resolution data analysis supplied by a core laboratory.


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Amy Furlong has been Executive Vice President of Cardiac Safety at ERT since December 2005, and previously served as Senior Vice President of Regulatory Compliance. She holds a Bachelor of Science degree in Biology and a Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University’s School of Pharmacy. Amy has more than 10 years of clinical research experience specialising in regulatory compliance and computer system validation.

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