iCardiac will use its proprietary Rapid QT service to optimize and accelerate subject enrollment
iCardiac Technologies, Inc., a leading innovator and provider of central core lab services, today announced that it has been selected to work on an early phase oncology clinical trial with a Japanese pharmaceutical company. The study will utilize iCardiac’s Rapid QT service offering, which enables trial sites to make more accurate patient inclusion/exclusion decisions.
Rapid QT is an expedited service for reviewing QT and other ECG-based intervals quickly – usually within two to four hours from initial collection – so that the results can be sent back to a site before the inclusion/exclusion decision about a subject is made. Providing an accurate set of ECG readings quickly ensures patient safety and that no subjects are inappropriately excluded or discontinued from a trial.
“Given the patient population in this study, it was more likely that some of the prospective subjects would exhibit longer underlying QT intervals or more complicated ECG morphologies,” said Brian Smith, Vice President of Project Operations at iCardiac Technologies. “However, the use of Rapid QT will minimize the likelihood that those underlying conditions will lead to incorrect enrollment decisions.”
Recent research efforts conducted separately by iCardiac and its industry peers each confirmed that there are often differences between QT readings conducted by a central core laboratory and those that are determined at a clinical site. These sites often rely heavily on automated measurement tools built into the site’s ECG device. Additionally, the research has indicated that those site-based measurements are more likely to be longer, and therefore overstate the actual QT reading.
“In addition to providing QT results in a speedy manner, our Rapid QT service utilizes a patent-pending platform for minimizing ECG measurement variability,” said Alex Zapesochny, President and CEO of iCardiac Technologies. “The combination of timeliness and accuracy uniquely positions Rapid QT as a valuable tool in minimizing incorrect enrollment decisions, thereby helping the industry to accelerate study recruitment and achieve earlier database lock.”
Rapid QT is part of iCardiac’s Tru-Enroll solutions, a suite of services that offers centralized access to accurate data in near real time.