spacer
home > epc > winter 2009 > the heart of the matter
PUBLICATIONS
European Pharmaceutical Contractor

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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

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.

spacer
Amy Furlong
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research

Philadelphia and London – June 10, 2019: CRF Bracket, formed by the 2018 merger of CRF Health and Bracket, today launched as Signant Health (signanthealth.com). Uniting eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite, Signant makes it easier to participate in – and sites and study teams to run – clinical trials. This intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable sponsors and CROs to extend the reach of drug development, expand patient opportunities and improve data quality.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement