Highly Automated QT addresses the dissatisfaction among pharmaceutical drug developers with the poor precision, high cost and long lead time of manual or semi-automated QT measurements. iCardiac’s Highly Automated QT method has now been validated in a number of clinical QT studies, including a cross validation against data from five leading ECG core laboratories, and has supported the submission of QT data to the FDA. As part of the core validation studies, University of Rochester independently performed the analysis of the ECGs and the results were sent to the FDA for statistical review. The extensive research and validation efforts have culminated in the Highly Automated QT method being recognized and accepted as equivalent to the manual evaluation of QT intervals by cardiologists in cardiac safety studies.

In addition to its unsurpassed validation profile, the Highly Automated method has been shown to provide significant benefits for development teams in comparison to more traditional studies conducted by ECG core laboratories:

• Reduce analysis variability by 20% to 60%.
• Reduce analysis time by as much as 80%.
• Reduce analysis cost by as much as 50%.

iCardiac’s Highly Automated QT technology is different from “fully automated” approaches – which are based solely on computers – because it combines advanced ECG signal processing algorithms developed over the past decade with a robust quality assurance process conducted by cardiologists. Specifically, the technology performs a precise automated QT measurement and subsequently, using sophisticated statistical models and algorithms, guides cardiologists to those ECGs that require attention and/or adjustment. Using this approach, only a portion of the entire Thorough QT (TQT) dataset requires manual over-reading, thereby generating significant cost savings to sponsors while at the same time providing assurance to the regulators as well as pharmaceutical companies regarding data quality.

The method has been validated in studies conducted with leading pharmaceutical companies, core laboratories, academic institutions and the FDA. In the studies, iCardiac analyzed more than 1.5 million digital ECGs gathered over the past decade from cardiac safety studies of marketed drugs, as well as from drugs that were terminated in development due to high cardiac risk.

Highly Automated QT can be combined with other iCardiac services to further increase the precision and cost effectiveness of a QT study and is offered in conjunction with iCardiac’s full set of CRO services covering study design, project management, data management and statistical analysis.

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