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Tuesday, June 20 • 10:30am - 11:30am
#220: Cardiac Safety

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Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Snehal N Kothari


Evaluating Attitudes and Experiences with Evolving Cardiac Safety Assessment Solutions
Kenneth A. Getz, MBA

The Power of Phase1 Studies to Detect Clinical Relevant QTc Prolongation
Jörg Täubel, MD, FFPM

avatar for Snehal Kothari

Snehal Kothari

Chief Medical & Scientific Officer, QuintilesIMS
Dr Kothari is Chief Medical & Scientific Officer for Quintiles IMS Cardiac Safety.He provides advice on all aspects of cardiac safety & directs the ECG core lab with an experience of over 15 years and spanning hundreds of studies. Trained in Mumbai & Paris, he is a Fellow of American... Read More →

avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development, United States
Ken Getz is a Professor and the Director of the Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded studies on pharmaceutical R&D management and execution; protocol design optimization; CRO and investigative site management... Read More →
avatar for Jorg Taubel

Jorg Taubel

Chief Executive Officer, Richmond Pharmacology, United Kingdom

Tuesday June 20, 2017 10:30am - 11:30am CDT
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Forum