An Academic ECG Core Lab Perspective of the FDA Initiative for Digital ECG Capture and Data Management in Large-Scale Clinical Trials

Abstract

Maximal utility of accessible data is attractive to all partners in clinical research, whether it directly improves patient care or more accurately allows identification of the safety and efficacy of a new drug or procedure. The Food and Drug Administration (FDA) has presented a guideline draft addressing digitization of electrocardiogram (ECG) data in clinical trials to improve the standards for collection, analysis, and storage of safety information on new medical therapies. This FDA initiative has led to discussions and collaboration among the FDA, the pharmaceutical industry, the electrocardiography manufacturers, and the academic as well as the nonacademic ECG core labs. In this article, we present a broad-based viewpoint from two groups of academic ECG core labs, the Alliance of Academic ECG Core Labs and the Virtual Electronic ECG Corelab International Consortium. We have chosen to widen the perspective from using digitized ECG data in safety trials only, as addressed by the FDA guideline draft, to a discussion on the possibilities and the potential problems when using digitized ECG data also in large clinical trials focusing on efficacy measurements. We conclude that the benefit of digital data mining is probably well worth an initial incremental effort and expense.