2024 - Benefits of Utilizing Early Precision QT and Artificial Intelligence-Powered Data Quality Assessments in Early Phase Trials

The probability of success (POS) for developing a new drug is 10% to 15% but is as low as 3% in oncology and up to 33% in ophthalmology. Most new drug entities, ~70% fail in Phase I or the first-in-human (FIH) trial predominantly due to unmanageable toxicity or poor pharmacokinetics. These findings highlight the importance of the FIH trial in drug development where the main causes for failure are assessed and dictate if an asset progresses to late-phase development or the whole program fails.
Increased efficiency could be realized if cardiac safety data are generated from studies performed earlier in the clinical development program. In single ascending dose (SAD) or multiple ascending dose (MAD) FIH studies, escalating doses of the new drug entity are given to small cohorts of subjects, often up to the maximum tolerated dose. Plasma concentrations are often, therefore, achieved which will not be exceeded in patients. While some SAD or MAD studies include more rigorous assessments for changes from baseline in QT and other electrocardiogram (ECG) intervals, more common is a safety assessment based on the Principal Investigator’s read of 12-lead ECG printouts. This approach cannot confidently detect changes in the QT interval at the precision level of a TQT trial. In response, iCardiac Technologies, acquired by Clario in late 2017, introduced a transformative cardiac safety testing method. Expert Precision QT (EPQT), to improve the overall productivity of pharmaceutical development and, in collaboration with The Food and Drug Administration (FDA), has been tested successfully in a comprehensive clinical trial.
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Join this webinar to gain insights into the evolving landscape of cardiac safety assessments and strategies for optimizing drug development outcomes.
Keywords: Clinical Trials, Drug Development, Clinical Research, Clinical Trial Data,  TQT Study, Clinical Data,  QT, First-in-Human, Cardiac Safety, Early Phase Clinical Trials, AI, PK, Cardiovascular Clinical Trials, Toxicology/Safety