Mobilise-D: sensor-measured walking

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

The Mobilise-D consortium, coordinated by the University of Newcastle upon Tyne and funded under the EU's Innovative Medicines Initiative 2 (total cost about EUR 49.9 million, EU contribution EUR 25.4 million, April 2019 to June 2024, per CORDIS grant 820820). Marco Viceconti is first author of its strategy paper, with Mazzà, Caulfield, Becker, Rochester and others. The request to the EMA was filed on 4 October 2019 by McRoberts B.V. on the consortium's behalf. In the US, a separate group filed a letter of intent for a wrist-worn "Virtual Motor Exam" with the FDA (the filing is undated and I did not confirm who submitted it).

What happened

Clinic rating scales (landmark 114) capture a short, staged moment. Mobilise-D planned to qualify "digital mobility outcomes" such as walking speed, stride length and number of walking bouts, measured by a body-worn sensor for seven days. The aim in this first request was a secondary, "monitoring" endpoint alongside the MDS-UPDRS parts II and III, with Parkinson's first and COPD, multiple sclerosis and hip fracture to follow. The clinical validation planned 600 participants at five centres in four European countries, followed for 24 months with visits every six months (Sensors 20:5920, 2020). The EMA's scientific advice group met on 9 to 12 March 2020, the CHMP adopted the advice on 23 to 26 March, and the letter of support (EMA/234828/2020) is dated 29 April 2020. It calls the technical and clinical validation approach acceptable and the stepwise plan reasonable, but says: "Digital quantification of mobility cannot, at this stage, be considered a primary endpoint, as a full validation of a complex tool is needed."

Why it moved us toward a cure

Disease-modification trials need sensitive, objective measures of slow change. Continuous sensors could detect smaller effects and allow remote visits. Mobilise-D's pipeline is being tested in a digital-measures sub-study of the UK platform trial EJS ACT-PD, and the EMA's 2025 revision concept asks about digital measures (landmark 118).

Outcome

Open. A letter of support is not formal qualification. A 2022 paper by the consortium (Viceconti et al., Front Med) reports two qualification requests (October 2019 and June 2020) and two EMA letters of support, and notes that only narrowly scoped requests have succeeded so far. I found no EMA qualification opinion or qualified digital endpoint for Parkinson's after that.

Sources

• EMA letter of support, 29 Apr 2020 (EMA/234828/2020)
• Viceconti et al., Sensors 2020;20(20):5920, DOI 10.3390/s20205920
• Viceconti et al., Front Med 2022;9, DOI 10.3389/fmed.2022.996903
• CORDIS record, grant 820820
• BGS poster on Mobilise-D in EJS ACT-PD
• FDA COA letter of intent, Virtual Motor Exam (undated)
• Not yet verified: whether the Roche PD app or Apple Watch measures are regulator-accepted (not checked); the second EMA letter of support (the 2022 paper reports it, I did not find the letter); the date and filer of the FDA letter of intent.