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Cardiac Safety
Session Chair(s)
Snehal N Kothari, MD, FACC
Chief Medical & Scientific Officer
QuintilesIMS, India
In December 2015, the ICH E 14 guidance was updated to reflect an expanded role for Concentration-Response modeling of QTc data accepting it as an alternative to the traditional by-time-point analysis as the primary basis for decisions to classify the risk of QT prolongation of a drug. Careful ECG evaluation in early phase studies using Exposure-response analysis can thus serve as a potential alternative to the E14 “thorough QT” study. This adds to protocol complexity in early phase studies. Stakeholder impressions and expectations of the revision in the guidance as well as potential challenges and opportunities including newer approaches to assessment of cardiac safety will be discussed. This session will describe with case studies how TQT grade ECG data can be collected in phase I studies. As the guidance indicates that a separate positive control may not be necessary, alternative approaches for protection against false negatives will be considered.
Learning Objective : Describe how cardiac safety assessment is evolving and changing; Discuss key aspects of QT assessment in phase I studies to support TQT waivers; Identify how ECG core lab processes influence data quality and assessment of QTc in phase 1 studies.
Speaker(s)
Evaluating Attitudes and Experiences with Evolving Cardiac Safety Assessment Solutions
Kenneth Getz, MBA
Tufts University School of Medicine, United States
Tufts Center for the Study of Drug Development
The Power of Phase1 Studies to Detect Clinical Relevant QTc Prolongation
Jorg Taubel, MD, FFPM
Richmond Pharmacology, United Kingdom
Chief Executive Officer