Developing Digital Mobility Outcomes for the Assessment of Mobility Performance: Lessons learned from Health Authority Consultations
Time: 1:00 pm
day: Day One
Details:
- Mobility disability, a limitation in real-world walking to carry out mobility-related activities of daily living (ADL), is one of the most well-recognized characteristics in chronic diseases such as Multiple Sclerosis and Parkinson’s Disease
- The Mobilise-D consortium aims to demonstrate that Digital Mobility Outcome (DMO) measurements of mobility performance in the real-life setting are sensitive and meaningful measures for mobility disability that complement mobility capacity and performance perception measures
- The consortium performed technical and clinical validation studies to identify one or more DMOs to serve as an electronic clinical outcome measure (eCOA) for regulatory decision making and consulted with EMA and FDA via qualification advice procedure and Drug Development Tools program, respectively
- In this talk the feedback received from the Regulatory Agencies and lessons learned will be summarized
