Novel Approach May Help to Prevent False Positive Cardiac Safety Findings in New Drug Development
PHILADELPHIA – April 10, 2014 –– ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced it has entered into an agreement with GE Healthcare that enables ERT to introduce the QT Guard Plus Analysis System to the clinical trial industry as part of its centralized cardiac safety solutions. The QT Guard Plus Analysis System enables biopharmaceutical companies to analyze detailed morphology of the ECG T-wave, which can help identify new drugs that have an effect on QT.
During clinical development, biopharmaceutical companies are required to conduct cardiac safety studies to evaluate if new drugs can trigger a potentially fatal disordered heart beat known as Torsades de Pointes (TdP). Since prolongation of the QT interval on the surface ECG provides evidence of the common mechanism by which drugs produce TdP, thorough QT/QTc (TQT) studies have become the industry standard for meeting this requirement. However, measurement of the QT interval can be difficult and has led to the termination of promising drugs that showed some degree of QT prolongation in early studies, but otherwise did not demonstrate evidence of proarrhythmia, a harmful effect.
The QT Guard Plus Algorithm identifies and quantifies characteristic changes in the shape of the T-wave found in drugs that produce TdP. The ability to perform this quantitative analysis can help to distinguish between drugs which are proarrhythmic and those which are not.
Recognizing the value of T-wave morphology assessment, GE – known for innovative healthcare solutions – and ERT, the market leader in cardiac safety in drug development, have teamed to introduce the QT Guard Plus Analysis System. ERT has incorporated this algorithm tool into its EXPERT® platform.
“We believe that T-wave morphology analysis may help to better assess the arrhythmogenic potential of drugs which have a small or equivocal QT effect, and may be a very useful adjunct to traditional QT studies,” said Dr. Robert Kleiman, ERT’s Chief Medical Officer. “The initial peer reviewed literature is very promising that T-wave morphology analysis may help improve cardiac safety while preserving the drug development pipeline.”
“By offering the QT Guard Plus Analysis System, ERT is delivering an innovative, reliable approach to QTc measurements that may open otherwise closed doors to biopharmaceutical researchers and ultimately, help them to deliver new medical treatments,” said Yuval Shaked, General manager Diagnostic Cardiology, GE Healthcare. “We are pleased to have worked with them on the introduction of this important new tool for measuring T-wave shapes for assessment of cardiac safety.”
ERT is delivering a complimentary webinar on May 1 entitled, “What to Do When a New Drug Has a QT Signal – The Use of T Wave Morphology analysis to Supplement QT Measurement.” To register, click here or for more information on ERT’s other proven cardiac safety solutions, please visit www.ert.com/cardiac.
About ERT
ERT (www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COAs) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling, and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
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