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Speakers for this Event: 

  • Dhiraj Narula, MD, MRCP UK, DM Card, FACC, FISE, Medical Director, Quintiles Cardiac Safety Services
  • J. Rick Turner, PhD, Senior Director, Quintiles Integrated & Translational Cardiovascular Safety
  • Jared Schettler, MS, Director, Quintiles Phase I Biostatistics

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This webinar will provide insight into the latest scientific and regulatory thinking around the use of early-phase QT data and concentration QT modeling as a predictor of cardiac risk, ultimately improving decisions about further development and future study design.

With increasing research and development costs and declining pipeline success, pharmaceutical companies need to be more discerning in early development by maximizing the data and insights gleaned in Phase I/IIa studies. Through evolving techniques and methods, researchers are exploring new ways to obtain more robust data before proceeding to larger, late-stage trials.

One such approach is through conducting more rigorous cardiac safety assessments in early Phase I trials. The cardiac safety regulatory landscape requires assessment of an investigational drug's proarrhythmic liability, currently operationalized as drug-induced QT/QTc interval prolongation. While rigorous QT/QTc measurements are taken in the Thorough QT/QTc (TQT) study, it is not typically conducted until relatively late in Phase II clinical development. However, more rigorous assessments in early Phase I trials can be very valuable in scenarios involving both "no-go" and "go" decisions. Reliable observation of an unacceptable degree of QT/QTc interval prolongation can enable an earlier, less costly "no-go" decision. Additionally, if a “go” decision is made, the initial data permits subsequent studies to be designed in the most resource-efficient manner while preserving full scientific integrity.

A good initial understanding of the degree of drug-induced QT/QTc prolongation, and also the variability in such prolongation seen among subjects, enables the TQT to be designed with the minimum necessary number of subjects, leading to a less expensive and shorter study, hence a shorter overall clinical development program.


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