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ROCHESTER, N.Y.—iCardiac Technologies Inc. is taking part in an industry-wide validation program organized by the Cardiac Safety Research Consortium, the company announced recently. The program seeks to enable a broader validation of an alternative approach to the Thorough QT (TQT) study. iCardiac is providing industry-wide access to its dataset as part of this effort, making it available to ECG core labs.
The Cardiac Safety Research Consortium is inviting interested ECG core labs to join the IQ-CSRC Study Waveform Sharing Program, which will grant the labs access to the validation dataset to test their ability to accurately characterize QT effects from each of the six drugs tested in the original IQ-CSRC validation study. A TQT study serves to evaluate any potential cardiac issues of a drug, namely its likelihood of causing arrhythmia.
“We are excited that the industry has reached this point and that this highly beneficial approach to definitive QT assessment is now becoming widely accepted,” said Alex Zapesochny, president and CEO of iCardiac. “We appreciate the leadership of the Cardiac Safety Research Consortium in overseeing this critical validation program and encourage our colleagues at other ECG core labs to participate in this effort to make drug development more efficient and effective.”
The dataset in question comes from the IQ-CSRC study and was collected and analyzed by iCardiac in 2014. That study played a role in the recent landmark regulatory revision by the International Council for Harmonization (ICH), which supported the use of the approach in which definitive QT assessment is conducted using ECG data collected from Phase 1 studies.
The terms of the program, as shared by the Cardiac Safety Research Consortium, state that participating laboratories will be blinded to the treatment arm information and the statistical analysis based on each laboratory’s measurements will be conducted by a neutral third party. The cutoff date for registering to participate in the program was Jan. 25.
This opportunity, says Zapesochny, “allows all of the ECG core labs to be able to validate their methodologies and their labs' ability on the same dataset, with that dataset being one that was very thoughtfully put together and designed. And what that is supposed to aim to do is to make sure that everyone in the industry and of course the users of the service, the pharmaceutical and biotech companies that use this type of service, to have as much comfort as possible and information around this new test.”
“From our perspective, the fact that now this ability is being provided to everybody is great because that means that the adoption of technique should happen much faster,” he adds.
Since the ICH adopted the E14 Guidance in 2005, almost every new compound seeking regulatory approval has needed to undergo a TQT study, a standalone trial typically run toward the end of or after Phase 2. The IQ-CSRC validation study was intended to determine if definitive QT assessment could be performed as part of regular Phase 1 studies as a way to save money and generate critical compound information earlier in the development process. In the wake of the study results at the end of 2014, the U.S. Food and Drug Administration has on occasion granted TQT study waivers based on this alternative.
A TQT study is expensive, Zapesochny explains, and as such, many companies put it off. With this new approach, organizations can both save money and, by taking the necessary data from early studies, get the requisite information one to two years earlier in the development process to better inform their decisions on whether and how to proceed.
“This is a rare opportunity for all ECG core labs to really be on the same footing, to be able to demonstrate their capabilities in this area,” he tells DDNews. “And we of course would very much encourage as many of our colleagues at other core labs to take advantage of this as possible. It's very rare that an opportunity like this, to all be validated on the same dataset, comes along.”