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Sponsors Are Guaranteed to Receive Precise, Conclusive Thorough QT Results or Pay Nothing
Rochester, NY – iCardiac Technologies, a market and scientific leader in the conduct of cardiac safety assessments, announced today that it has launched the industry’s first full risk-sharing program for Thorough QT studies. Leveraging its innovative High Precision QT™ methodology for analyzing ECG waveforms, iCardiac’s program guarantees to sponsors that one of two desirable outcomes will be achieved. Specifically, their Thorough QT study results will either (1) reflect a clean, negative study (i.e. the QTc effect of the highest dose of the drug will have a confidence interval upper bound lower than the 10 millisecond regulatory threshold of concern, while the positive control will demonstrate assay sensitivity), or (2) indicate that a positive result is actually an accurate one, in that the precision of the study (measured by the standard deviation of change from baseline QTcF) will be at or below 8 milliseconds for a crossover study (and at or below 9 milliseconds for a parallel study), while the positive control arm of the study will demonstrate assay sensitivity. If neither of these two desirable outcomes is achieved, a sponsor will pay nothing to iCardiac.
The premise behind the risk-sharing program lies in the central role that precision plays in the successful conduct of Thorough QT studies. The FDA has previously reported that approximately 12% of all Thorough QT study results submitted between 2006 and 2013 were deemed to be “inconclusive.” Poor precision is among the leading causes of such inconclusive results, which sometimes occurs when an ECG core lab powers a study based on an expectation of achieving a precision level that it does not actually achieve when it runs the study. An even greater concern with poor precision is the risk of a false positive QT result for a promising compound. Approximately 20% of all Thorough QT results submitted to the FDA from 2006-2013 were deemed to be “positive” for QT prolongation, and undoubtedly some of those were actually false positive results due to poor precision causing a widening of the confidence intervals pertaining to the study.
“With nearly a third of all Thorough QT studies historically resulting in either inconclusive or positive results, it is absolutely crucial for sponsors to choose an ECG core lab that can and will provide the kind of precision that optimizes the likelihood of a successful study.” said Alex Zapesochny, President and CEO of iCardiac Technologies. “Since it is the ECG core lab that is in the best position to assure a highly precise study, sponsors have the right to expect ECG core labs to assume responsibility for risks associated with poor precision, and we at iCardiac are happy to fully do so.”
“Through many years of innovation and millions of dollars of investment, iCardiac has developed a precision methodology that reliably results in a standard deviation of 6 to 7 milliseconds, while the rest of the industry more typically obtains a standard deviation of 9 to 11 milliseconds,” said Dr. Borje Darpo, a cardiologist and iCardiac’s Chief Scientific Officer. “That improved precision is critical to minimizing the risk that a Thorough QT study will end in an inconclusive or false positive result, and iCardiac now effectively guarantees this performance level to all sponsors.”
iCardiac’s full risk-sharing program is applicable to studies in healthy subjects conducted at an iCardiac Certified Site, or at a clinical site approved by iCardiac. Not all Thorough QT studies are eligible, and this risk-sharing program will only be deemed to be in effect if it is part of an executed, written contract between iCardiac and a sponsor. For a full list of terms and conditions, sponsors should contact an iCardiac representative.