Improve Effectiveness of Cardiac Assessments in Early Phase Trials with Early Precision QT and AI-powered Data Quality Checks

Early and accurate Phase I data is crucial to maintaining safety and determining the viability of new drug entities. Cardiac safety assessments, particularly those focused on the QT interval, play a key role in assessing potential toxicity and guiding portfolio decisions. Therefore, accurately evaluating cardiac safety earlier in the development process may save time, resources and costly future studies.

Traditionally, QT assessments have been conducted in later stages of clinical development in Thorough QT (TQT) studies. However, a more proactive approach is available: early phase QT assessments performed in healthy volunteers during Phase I studies. However, relying on the site investigator’s interpretation of 12-lead ECGs typically does not provide the precision needed to detect QT interval changes at the threshold required by health authorities in support of a QT waiver.

By combining high-precision, early-phase QT assessments from the early precision QT (EQPT) methodology with AI-enabled ECG quality checks, drug developers can obtain actionable safety data that informs critical decisions early in the development process. This proactive assessment of cardiac safety risks can help mitigate potential toxicities before they escalate, improving the likelihood of successful drug development and reducing the risk of late-stage failures.

In many cases, early-phase findings can support a waiver of a dedicated TQT study, reducing the need for a costly and time-consuming trial later in development.

Register now to gain a clearer understanding of EPQT to ensure data quality, create efficiencies and potentially qualify for a TQT waiver.

Speakers

(Moderator) Vic Patel, MD, PhD, Vice President & Chief Medical Officer, Cardiology, Clario

Dr. Vic Patel is board-certified in cardiology and holds a PhD in Biophysics, having conducted extensive research on arrhythmia mechanisms. For 11 years, he served as a Faculty Member at the University of Pennsylvania School of Medicine, where he directed the Molecular Arrhythmia Research program and practiced clinical electrophysiology. Dr. Patel spent the next eight years in drug development and cardiac safety as a Clinical Development leader and therapy area head across all phases. At Clario, Dr. Patel oversees Cardiology Consulting and ECG/Holter core lab services and leads the Biostatistics and Medical Writing groups.

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Dr. Borje Darpo, MD, PhD, Chief Scientific Officer, Cardiac Safety, Clario

Dr. Borje Darpo has held key roles on projects in all phases of clinical development. He has authored internal QT guidance documents for the design and conduct of clinical QT assessment. In collaboration with industry-leading cardiac safety experts and the US Food and Drug Administration, Dr. Darpo led the IQ-CSRC study, which validated the concept of applying exposure-response analysis on data from early-stage clinical trials to replace the TQT study. In addition to his role at Clario, he is an Associate Professor of Cardiology at the Karolinska Institute in Sweden.

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Jean-Philippe Couderc, PhD, MBA, Professor of Medicine and Computer/Electrical Engineering, University of Rochester

Jean-Philippe Couderc is a Scientist with experience in the development of groundbreaking technologies in Quantitative Electrocardiography and Cardiac Safety. He is internationally recognized as an authority in the development of computerized technologies related to cardiology. He is the Scientific Founder and Chief Technology Officer of iCardiac Technologies Inc. Dr. Couderc is also the Founder and Director of the Telemetric and Holter ECG warehouse, an initiative developed with the US FDA under a private-public partnership and funded by the National Institute of Health. It is characterized by a creative mind leading to translational scientific discoveries, which have been highlighted by major media, including the Wall Street Journal.

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