In the first year of Mobilise-D, we asked the European Medicines Agency (EMA) for qualification advice for Digital Mobility Outcomes (DMOs). EMA just published their letter of support that publicly endorses our initial stage in the wider objective of the Mobilise-D Consortium to pursue the qualification of Digital Mobility Outcomes (DMOs) as monitoring biomarkers of mobility performance in regulatory drug trials. We have now got support to continue our work towards regulatory approval of DMOs as biomarkers! You can read the full letter of support here.
Monitoring patients’ mobility during the COVID19 pandemic could easily have been impossible due to lockdown and restrictions such as social distancing. However, this isn’t the case for the Mobilise-D technical validation study (TVS) where 120 participants with chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, congestive heart failure, or hip fracture, along with healthy older adults, will be enrolled. Our test sites in Newcastle and Sheffield have found a way to work around the distancing restrictions to keep the study open, and confirmed that the technical validation study testing will continue despite the 2nd lockdown in the UK.
Measuring real-world mobility outside the lab with a Gold Standard system is no mean feat. Our Mobilise-D partners at the University of Sassari in Sardinia (UNISS) have developed the INDIP system which is currently being used in the ongoing technical validation study. But for the INDIP to work smoothly at our test sites in the UK, Germany, and Israel, a lot of hard work is necessary from many people. In this video, you get a small peek behind the scenes at UNISS.
Being able to remotely monitor patients’ mobility in their natural environment is a major advantage, both in lockdown and in general. To meet the societal need for better mobility assessment, Mobilise-D will follow up the ongoing technical validation study with a large-scale clinical study that will include 2400 patients from four different cohorts across different sites in Europe.
Mobility is often said to be a sixth vital sign, just as important as other vital signs such as blood pressure and heart rate, and the key to independence in our daily life. But what does mobility actually mean for people? And what happens when they experience mobility loss?
We asked several people what the importance of mobility is for them, and what the impact was when they experienced mobility loss. Here are some of their answers.
Prof. Lynn Rochester and Dr. Ronenn Roubenoff explain how mobility is a vital sign and the benefits of being able to measure people’s mobility in a reliable way. To achieve a robust digital mobility outcome, Mobilise-D will first have to overcome a few challenges. More about this in the video.
Mobilise-D technology for remote monitoring of patients’ daily-life mobility! Interview with Lynn Rochester, Professor of Human Movement Science, Institute of neuroscience, Newcastle University, the Academic Lead of Mobilise-D and Ronenn Roubenoff, Global Head, Translational Medicine Discovery & Profiling, Novartis Institutes for Biomedical Research, the EFPIA Co-lead of Mobilise-D.