Research implications of the FDA ECG warehouse and related resources.

ABSTRACT

The electrocardiogram is often used as an efficacy endpoint for comparing new drugs or as an indicator for cardiovascular safety in both studies of arrhythmic and non-arrhythmic novel drugs. The FDA ECG Warehouse data are owned by the submitting entities, generally pharmaceutical company manufacturers. However, a subset of these ECG data was released with permission from the data owners to the CSRC for access by investigators, equipment manufacturers and algorithm developers for CSRC-approved research and development studies. This article provides an overview of the Cardiac Safety Research Consortium (CSRC) ECG Warehouse, including data availability, completed and ongoing projects, as well as future growth potential amidst an ever expanding FDA ECG Warehouse. Given that current ICH E14 guidelines request that sponsors submitting new drug applications assess the effects on the QT interval using a thorough QT (TQT) or dose-ranging study with concentration-QT analysis during early clinical development to assess cardiac risk, developing novel methods to determine cardiovascular safety, as well as understanding current ECG collection and analysis methods are prudent. The ability to utilize previously collected ECG data for secondary analyses improves cardiovascular safety by multiplying the scientific contribution of the original research.