Improve Effectiveness of Cardiac Assessments in Early Phase Trials

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.

You can register for the live event and get access to the recording here:https://xtalks.com/webinars/improve-effectiveness-of-cardiac-assessments-in-early-phase-trials-with-early-precision-qt-and-ai-powered-data-quality-checks/