As part of its program to prevent drugs with cardiac safety problems from reaching the market, FDA requires products in development to be tested for their tendency to lengthen the heart’s QT interval. This guidance (ICH E14), issued in 2005, adds substantial costs and time to clinical trials. Drug developers must collect ECGs from trial participants and then hire expensive cardiologists to perform the QT measurements by hand.
That’s changing now thanks to an innovative approach from iCardiac Technologies, Inc. The company has completed the industry’s largest validation study for an automated ECG analysis technology. The FDA has reviewed the data and told the company that it would consider such analyses acceptable as part of drug approval submissions.
According to the press release (iCardiac Completes Industry’s Largest Validation Study of Highly Automated QT Analysis; Represents First Automated Approach to Comply with Regulatory Guidance):
In the validation study, conducted with leading pharmaceutical companies and academic partners, iCardiac’s highly automated QT method has demonstrated results equivalent to manual measurements performed independently by U.S. board-certified cardiologists. iCardiac’s highly automated QT method was shown to reliably detect the effect of the drug moxifloxacin. Moxifloxacin is used as a positive control in cardiac safety studies and is included in the FDA’s E14 industry guidance.
“iCardiac’s highly automated QT analysis provides drug developers with the cost advantages of automation – which are significant – without compromising the rigor of drug safety testing,” said iCardiac’s Co-Founder and Executive Vice President Sasha Latypova. “We leverage validated algorithms and keep cardiologists involved at critical decision points. This principle has been successfully applied in many fields where safety is of paramount concern, such as air traffic control systems and energy generation.”
The results of the completed validation study were presented at the FDA’s interdisciplinary review team (IRT) meeting in August and will be published by iCardiac and its partners over the coming months. This study is part of iCardiac’s broader validation program that aims at both reducing the cost of cardiac safety studies and developing the next generation of ECG biomarkers that are more predictive than the QT interval for characterizing arrhythmia risk associated with novel medicines.
If the pharmaceutical industry is to get back on track it needs to embrace technologies like this one, which reduce costs and speed up trials.
For more information you can contact Sasha Latypova at (617) 359-7088.
I am a board member of iCardiac Technologies.