TQT 100% Risk Sharing
iCardiac Offers the Industry’s First and Only Full Risk-Sharing Program for Thorough QT Studies
Sponsors Are Guaranteed to Receive Precise, Conclusive Thorough QT Study Results or Pay Nothing to iCardiac
iCardiac Technologies offers the industry’s first and only full risk-sharing program for Thorough QT studies. Leveraging our innovative High Precision QT methodology for more accurately 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 arm will demonstrate assay sensitivity),
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 for our analysis services.
What Enables iCardiac to Offer 100% Risk-Sharing in Thorough QT Studies?
Simply put, it’s our superior ECG measurement precision. iCardiac has dedicated itself from its inception to developing the most precise methodologies and technologies for measuring QT in clinical trials, and we have fully succeeded. Optimal precision plays a central role 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 related to 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.
Given the many years of innovation and the millions of dollars of investment that iCardiac has dedicated to optimizing QT measurement precision, we now reliably achieve a standard deviation of 5 to 7 milliseconds in our Thorough QT studies, while many in the industry more typically obtain a standard deviation of 9 to 11 milliseconds. That improved precision from iCardiac is critical to minimizing the risk that a Thorough QT study will end in an inconclusive or false positive result, and iCardiac now effectively extends and guarantees this performance level to sponsors through our unique risk-sharing program.
Why Did iCardiac Create the 100% Risk-Sharing Program?
First, we wanted to cut through the noise and confusion that exists in the ECG core lab marketplace today. We recognize that all ECG core labs claim to have great precision, and that some core labs may even offer up an example or two (usually a non-published study) of when they were able to achieve good precision in some past study. But what sponsors really need to know is whether an ECG core lab can consistently and reliably achieve great precision in their next study. Given iCardiac’s long and documented history of achieving great precision in Thorough QT studies, we decided to try to make the decision very simple for sponsors: iCardiac fully commits itself financially with regard to our ability to achieve the precision a study truly needs. Will the other ECG core labs bidding on your study stand behind their results in the same way?
Second, we believe that risk-sharing is the fair and appropriate thing for all ECG core labs to do in the context of Thorough QT studies. After all, since it is the ECG core lab that is in the best position to control for the variables that might cause poor precision (such as training of the site) and to otherwise 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.
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 (such as those where the drug is a known QT prolonger), 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 or for other information about this risk-sharing program, please contact iCardiac.