The validation program is the latest milestone driving the rapid adoption of the new approach
January 11, 2016, Rochester, NY – iCardiac Technologies, Inc., a scientific leader in the conduct of cardiac safety assessments, today announced it is providing industry-wide access to its pivotal dataset as part of an effort announced by the Cardiac Safety Research Consortium to enable broader validation of an alternative approach to the Thorough QT (TQT) study. The pivotal dataset being made available to ECG core laboratories as part of this program comes from the IQ-CSRC study and was originally collected and analyzed by iCardiac in 2014. This study played a key role in last month’s landmark regulatory revision enacted by the International Council for Harmonisation (ICH) that supported the use of the approach in which definitive QT assessment is conducted using ECG data collected from routine Phase I studies.
Interested ECG core laboratories are being invited by the Cardiac Safety Research Consortium to participate in the IQ-CSRC Study Waveform Sharing Program, through which those laboratories will receive access to the validation dataset. Participating ECG laboratories will have the opportunity to utilize the dataset to test their laboratory’s ability to accurately characterize QT effects from each of the six drugs that were tested in the original IQ-CSRC validation study. Prior to this validation program, iCardiac had been the only ECG core laboratory to have validated its analysis capabilities on this critical dataset.
According to the program terms released by the Cardiac Safety Research Consortium, each participating core laboratory 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. This process will ensure fairness toward all participants and reflects the conditions under which the original validation study was analyzed. To participate in this program, core laboratories will need to indicate their interest to the Cardiac Safety Research Consortium by January 25, 2016.
The announcement of this validation program, which was planned as part of the 2014 IQ-CSRC study activities, represents yet another recent milestone toward broader adoption of an alternative path to the TQT. Since the ICH originally adopted the E14 Guidance in 2005, nearly all new compounds seeking market approval have been required to conduct a TQT study, a costly stand-alone trial that sponsors typically run toward or after the end of Phase II. The IQ-CSRC validation study was organized by industry and regulatory thought leaders to test whether definitive QT assessment could be done as part of routine Phase I studies, saving costs and providing critical information much earlier in the clinical development process. After the IQ-CSRC results were released at a meeting organized by the Cardiac Safety Research Consortium at the U.S. Food and Drug Administration (FDA) headquarters at the end of 2014, the FDA has, in some cases, granted TQT study waivers based on this alternative approach. Last year culminated with the ICH adoption of revised guidance language supporting the approach.
“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.”
Given its unique role and history with the validation of this alternative approach, iCardiac is conducting two free public webinars to explain the new ICH guidance and how to conduct such studies successfully.
To register for one of iCardiac’s free public webinars, visit:
– For January 12 at 10 a.m. EST/4p.m. CET: http://bit.ly/1YmOjnD
– For January 20 at 1 p.m. EST/7 p.m. CET: http://bit.ly/1IZ9l4B
For further information, please visit: www.icardiac.com