Unparalleled Capabilities in Conducting Thorough QT Studies
Thorough QT trials (TQT) form the cornerstone of cardiac safety evaluation and represent a critical step in market approval. While a majority of TQT studies have been successfully conducted following standard study designs and ECG analysis tools, a surprising portion of results obtained using conventional methods, despite large sample sizes, have historically proven to be “inconclusive” or cases of potential false positive QT prolongation. Inconclusive TQT studies are often based on the inability to achieve measurement precision levels which were assumed when designing the study.
iCardiac was originally formed in 2006 based on over two decades of leading peer-reviewed research to address the common challenges found with evaluating cardiac safety in drug development. Our proprietary High Precision QT (HPQT) methodology significantly improves the precision of ECG analysis in QT trials, driving an up to 60 % improvement compared to conventional, semi-automated ECG reading techniques.
The increased precision, cost-efficiency, and reliability offered by iCardiac has enabled us to become the most prolific TQT ECG core laboratory in the world. We have successfully completed numerous TQT trials, with many resulting in regulatory market approval.
Higher Precision = Fewer Instances of Inconclusive Positive Results
Precision plays a central role in the successful conduct of TQT studies. The U.S. Food and Drug Administration has previously reported that approximately 12% of all TQT 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 a study is powered using an assumed level of precision which simply is not achieved during study conduct. In the face of “inconclusivity,” sponsors and regulators cannot confidently exclude a QT effect at the threshold of regulatory concern, which may lead to an adverse drug warning label or an inappropriate decision with regard to market approval or further development of that drug.
In contrast, in the past six years, iCardiac’s HPQT method supporting over 50 TQT trials has resulted in 100% conclusive results for our sponsors. And in cases where QT prolongation is positive, our excellent measurement precision enables our sponsors to proceed with development decisions with full confidence that the effect seen in the TQT study is real.
Further, with iCardiac’s superior precision, we routinely provide TQT study design consultation to aid sponsors in conducting trials with 20-30% fewer subjects at the same level of statistical confidence. Smaller cohorts with fewer subjects translates to significantly lower total cost of the project.
Our Unique Programs: Full Risk-Sharing and Certified TQT Sites
As an industry leader in the conduct of TQT studies, iCardiac has developed two unique programs to assist sponsors:
Full Risk-Sharing: iCardiac is the only core laboratory in the industry providing full risk-sharing to sponsors for TQT studies. If your TQT study is eligible, iCardiac will guarantee that your TQT study results will be precise and conclusive.
Certified Site Program: iCardiac has trained and certified several well-known Phase I sites based on their proven capabilities in the conduct of TQT studies and the collection of highly reliable ECG data. This enables iCardiac to assist sponsors with optimal site selection for their TQT needs.