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International Clinical Trials

ECG's Digital Future

During drug development, early phase clinical trials are carried out in specialised units under optimal conditions for executing reliable studies, with the greatest respect for volunteer safety. These clinical facilities are highly specialised and personnel are carefully trained in performing clinical studies. Increasingly, they are equipped with powerful medical devices useful in analyses and measurements which are used in the evaluation of a test compound.

In relation to cardiac safety monitoring, the following three methods have historically been used:

  • Telemetry for continuous cardiac safety monitoring
  • Holter ECG for ambulatory, long-term recording of cardiac activity
  • Rest ECG to obtain a snapshot of cardiac activity at a specific time point

Over the past 10 years, the industry has been witness to a major evolution in relation to the hardware used in ECG recording, and more specifically with the introduction of digital technology. In parallel with this technological evolution, regulatory authorities have increased their requirements for submissions. For example, a pharmaceutical company submitting a thorough QT/QTc study to the FDA must provide annotated ECGs in an electronic format (1). This, in turn, has pushed clinical units to update their equipment concerning ECG management. Admittedly, this update is a significant financial investment, mainly due to user training and system validation. However, this investment is rewarded as it provides the opportunity to go even further when it comes to cardiac safety. This is made possible in part by implementing a full system for collecting and managing information: the creation of an ECG warehouse.


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Philippe LíHostis has been with Biotrial for over 10 years and was recently promoted to Head of the Central Lab. He was previously Head of Data Management and holds a MSc in Statistical and Numerical Engineering. Philippe brings important leadership to the central lab, building on his expertise in data management, as well as his overall knowledge in clinical research. Among other areas, his attention is currently focused on the development of new methods of analysis and signal processing in collaboration with university partners.

 

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