In the first year of Mobilise-D, the project 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 their initial stage in the wider objective of the Mobilise-D consortium to pursue the qualification of DMOs as monitoring biomarkers of mobility performance in regulatory drug trials.
Following the first advice, they submitted a second request for Qualification Advice in June 2020. With this follow-up request, they 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 the Consortium’s progress with DMO’s and regulatory approval! You can read the full letter of support here.
This article was originally posted on: https://www.mobilise-d.eu/ema-public-support-for-mobilise-d-follow-up