In the first year of Mobilise-D, we asked the European Medicines Agency (EMA) for Qualification Advice regarding Digital Mobility Outcomes (DMOs). EMA published their first letter of support in April 2020 that publicly endorsed 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.
Following the first advice, we submitted a second request for Qualification Advice in June 2020. With this follow-up request, we sought EMA’s feedback on the clinical concept to validate disease-specific and disease-independent DMOs as monitoring biomarkers, on the observational study to validate DMOs in four diseases (Parkinson’s Disease, Chronic Obstructive Lung Disease, Multiple Sclerosis and Proximal Femoral Fracture), and on the clinical concept to validate DMOs as surrogate endpoint, predictive of clinical outcome.
The EMA has now published their second letter, informing the wider community on our progress with DMO’s and regulatory approval! You can read the full letter of support here.