Qualifying Digital Biomarkers ‘Much Easier Now’ Thanks To EMA Efforts

The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.

Medicine doctor hands with digital medical interface icons on blur background, Medical technology and healthcare smart watch concept.
Digital endpoints are clinical outcomes gathered outside of the clinical setting, usually through devices like wearable sensors • Source: Shutterstock

Entities involved in developing and validating digital endpoints for use in clinical trials will find things are much easier now than seven years ago. The current process for regulatory qualification of digital endpoints is more established and the regulators have a much better understanding of the issues involved on this front.

These views were expressed by Laurent Servais, professor of pediatric neuromuscular diseases at the University of Oxford in the UK, who along with many others helped develop the first digital endpoint – real-world walking speed as measured by an ankle-worn device – to be qualified by

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