FDA: Study Demonstrates Potential for Faster Drug Development

On December 12 the Food and Drug Administration (FDA) hosted a full day 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 than current practice in clinical development. The definitive validation of this approach included cardiac safety studies for five marketed drugs for which cardiac safety profiles are well known. The testing was performed in a study design routinely used by pharmaceutical developers to characterize the safety of new compounds when given to humans for the first time (First-in-Human studies). This validation program utilized the proprietary Early Precision QT methodology developed by iCardiac Technologies to analyze the electrocardiogram (ECG) data collected in the study in a blinded way, and compare it to the known outcomes for each drug.

The results show that the Early Precision QT methodology substantially increases the data analysis precision over historical data analysis methods.  This increase in precision enables moving the definitive cardiac safety testing upstream in the pharmaceutical R&D pipeline, from large and expensive studies in later phases to smaller and earlier First-in-Human studies. 

Additionally, this approach delivers a much lower expected incidence of inconclusive results in comparison to historical assessment methodologies. The implications for the drug development process are very significant and include the potential to reduce the cost and increase the speed and reliability of cardiac safety testing.  This could reduce the over-reliance in the future on the more expensive Thorough QT (TQT) tests that have been used over the past 10 years.

“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", said 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, visit our website at www.earlyprecisionqt.com or download our White Paper at www.earlyprecisionqt.com/iq-csrc-white-paper-download.