Today’s smartwatches and activity bracelets, like FitBit, Apple, and Samsung, have motion sensors that can measure your daily activity. These technologies can tell you how much or little active you are, for example by counting your daily number of steps, heart rate or track your movements with GPS. In both basic and clinical research, similar technologies are used to measure different features of mobility in a real-world setting. What if we could use these technologies to evaluate how a new treatment or medicine affects patients with diseases that have a negative impact on their mobility? That would be amazing, right? However, until recently this could not the done yet for two main reasons.
The first is that standard technologies like the ones mentioned above do not work reliably in people who walk slowly, like many patients do, or in picking up gradual declines in mobility. The good news is that the Mobilise-D consortium is developing and validating new technologies that will solve this problem by tracking how you move, not only how much. The second reason is that before you can use a new technology for testing a medicine, that technology must be evaluated by the European Medicine Agency, the agency of the European Union in charge of the evaluation and supervision of medicinal products. In a new Mobilise-D publication, “Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes”, Marco Viceconti and colleagues describe in detail the approach that was proposed to the European Medicine Agency. The first phase in this approach was to evaluate whether the technologies developed and validated in Mobilise-D can be used to test new medicines for patients with Parkinson’s Disease – an approach that the European Medicine Agency considered appropriate. Being the first in its kind, this experience will help other researchers and pharmaceutical companies to develop their regulatory strategies around the use of digital health technologies.
Check out the paper here!