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news.The Food and Drug Administration hosted the Cardiac Safety Research Consortium (CSRC) meeting to release the results of the IQ-CSRC Study demonstrating the ability to conduct robust cardiac safety characterization several years earlier in clinical development.
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The study, which recreated five earlier drug cardiac safety studies, utilized the proprietary Early Precision QT methodology developed by iCardiac Technologies.
The results show highly significant improvement in precision and a much lower expected incidence of inconclusive results in comparison to historical assessment methodologies.
The implications for the drug development process are hugely important and include the potential to receive an FDA waiver for costly later stage Thorough QT (TQT) testing.
"Access to more accurate cardiac safety data early in the clinical trials process can mean accelerating the development of promising drugs that might have been canceled due to inconclusive or inaccurate results from the manual assessment processes currently in use by traditional ECG core laboratories", comments Alex Zapesochny, President and CEO of iCardiac Technologies.
"The Early Precision QT methodology analyzes over 100 times the data when compared to traditional analysis methods, offering much earlier insights into the viability of drugs in development."
The study, which was designed by a team including the FDA, iCardiac Technologies, and the Cardiac Safety Research Consortium, offers the potential for significant cost savings and earlier commercialization of promising new chemical entities in the immediate future.
For details on the IQ-CSRC Study and the implications for drug developers, core labs, and clinical development planning.