An article in Computers in Cardiology formally documents the FDA’s conclusion that iCardiac Technologies’ highly automated methodology, COMPAS can be considered as a robust alternative to manually reading ECGs in Thorough QT Studies. This is the first automated technology considered equivalent by the Agency.
From the press release:
In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision and high cost of the “gold standard” manual QT measurements has led to multiple efforts toward automating QT interval measurement.
The FDA, however, has not accepted fully automated QT analyses, which rely solely on computerized analysis, in cardiac safety studies. The FDA has expressed concerns that measurements provided by ECG machines are not precise enough for use in clinical trials and that even the most sophisticated algorithms cannot consistently and reliably detect the effects of an entirely novel drug on the QT interval.
Highly Automated QT technology from iCardiac combines advanced ECG signal processing algorithms developed over the past decade of electrophysiology research at the University of Rochester with a robust, human-based, quality assurance process. The technology performs a precise automated QT measurement while applying sophisticated statistical models and algorithms that guide cardiologists to those ECGs that require human attention and/or adjustment.
With this approach, only a small portion of the entire TQT (Thorough QT) dataset requires manual over-read, thereby generating significant cost savings to sponsors while at the same time providing assurance to the regulators regarding data quality.
I am a board member of iCardiac.January 21, 2009