Quality to the Core

Recent regulatory guidance for electrocardiographic (ECG) analysis has raised new considerations and challenges for sponsors when designing drug development programmes. As part of these initiatives, the role of the ECG core laboratory has been redefined as a ‘trusted third party’ for the generation, management and delivery of digital ECG files. As a result, mandatory quality programmes for the ECG core laboratory have expanded from assuring the accuracy and precision of key ECG endpoints to now including a complex combination of evolving technologies, processes and data verification techniques in the collection, evaluation and management of digital data files. The successful collection of quality ECG data in the digital era is highly dependent upon superior technology and user training based on predefined processes to properly collect, identify and process ECGs.

To this end, there are several logistical, equipment, data and record management issues that the ECG core laboratory must undertake, in addition to the clinical ECG analysis methodology itself. There are a number of technology solutions, ECG analyses, evaluation methodologies and data management decisions to be made. In the definition of adequate and wellcontrolled ECG studies, a balance of these factors must be found to determine the approach that best suits each protocol. The ECG core laboratory should have the flexibility and experience to make these decisions in a validated and controlled environment.