A Comparative Analysis of Holter Recordings from a Thorough QT (TQT) Study Using Highly Automated Systems vs. a Standard Semi-Automated Method

• Activity Number: 305
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Li Fan*+ and Patrick J. Larson and Anis Khan and David Gutstein and Matt S. Anderson
• Companies: Merck and Merck and Merck and Merck and Merck
• Keywords: Highly automated method ; Semi-automated method ; TQT

Abstract

To detect a potential pro-arrhythmic effect of non-antiarrhythmic drugs, a thorough QT (TQT) study is warranted in most cases. However, the TQT study represents a substantial expense and at present typically requires a large sample size for adequate power. Recent advances in automated ECG data analysis platforms, referred to as highly automated (HA) analysis algorithms, have been purported to reduce the variability of the standard semi-automated (SA) approaches that are currently in use and increase consistency across studies. To compare the performance characteristic of five HA platforms with an SA method, we summarize a comparative analysis using a reference data set. Statistical analyses included agreement between QTcF from the HA methods vs. the SA method and variability estimations for core ECG intervals for each HA method and SA method. Based on the quantitative assessment of agreement and variability, clinical utility index was used for the integrated assessment and scientific recommendation.