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Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement

Periodic Reporting for period 2 - MOBILISE-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement)

Reporting period: 2020-04-01 to 2021-03-31

The ability to move is a key contributor to “physical, mental and social well-being”, however, the study of mobility has received little attention, except in diseases characterised by specific mobility dysfunction. The increasing longevity of the world’s population together with prolonged survival in many chronic diseases means that more people are suffering from loss of mobility, which in turn is a major determinant of loss of independence. This has a considerable and growing personal, societal and economic impact.
The objectives of MOBILISE-D are to: (i) deliver a robust, validated, technology independent solution, within a standards-based framework, for digital mobility assessment; (ii) provide evidence that the outcomes accurately measure and monitor disability and predict clinical outcomes in four of the most relevant mobility-limiting conditions and (iii) obtain regulatory, payer and health technology agencies approval of digital mobility outcomes. In addition, European Federation of Pharmaceutical Industries and Associations (EFPIA) partners will conduct exploratory studies in Congestive Heart Failure (CHF).
Mobilise-D’s ultimate goal is to provide a validated, robust set of algorithms to measure Digital Mobility Outcomes (DMOs) that informs therapeutic development, clinical practice, precision medicine, industrial development and stakeholder approval. Successful achievement of this goal will facilitate the development of drugs and other therapeutic interventions; provide a roadmap for clinical implementation.
Work Undertaken and Key Results
Within the first year of Mobilise-D, algorithms and specifications for DMO’s and datasets were identified and tested in preparation for the Technical Validation Study (TVS). Methodologies and protocols were developed to implement the TVS along with an assessment of confounding, human factors and statistical analysis requirements. In addition, gold standard tools for the TVS study have been developed, ethics approval for the study obtained, the data management platform was developed along with data ingestion tools and a specification for electronic Clinical Outcome Assessments (eCOAs). In year 2 the TVS to validate data assessment algorithms for Digital Mobility Outcomes (DMO’s) was undertaken. Unfortunately, this started just as COVID-19 began to lockdown Europe which has led to a 6 month delay in concluding the study. Currently about 80% of patients have been recruited, with a revised conclusion date of September 2021.
Within year 2 preparation for the Clinical Validation Study (CVS) due to start in year 3 of the project commenced. Cohorts for each of the 4 conditions of interest (Multiple Sclerosis (MS), Chronic Obstructive Pulmonary Disease (COPD), Parkinson's Disease (PD) and hip fracture) were identified, together with lead experts. An overarching literature search has been completed on DMO’s to understand the current state of the art in mobility assessment across the cohorts and to inform the choice of DMO and clinical outcome assessments for use in the CVS.
A large amount of work has gone into mitigating the risks associated with COVID-19 and the unpredictable nature of lockdowns across Europe. Building on the work of the TVS, the protocols, ethics, training, site agreements etc. have been developed and implemented. A clinical validation task force was setup to integrate work from all project perspectives and to manage risks. This has directly led to the start of the Clinical Validation Study starting on time.
The project has requested 2 rounds of Qualification Advice from the EMA and received a letters of support for the first round of advice. Mobilise-D is currently considering an approach to FDA and also how to best to proceed with EMA Qualification Opinion.
Mobilise-D and another IMI project, IDEA-FAST have agreed to collaborate in non-confidential areas. A significant output of this is the Digital Health Catalyst (DHC) (www.digitalhealthcatalyst.org) which aims to provide a platform for the advancement of early career researchers in field of digital health.
Mobilise-D has also developed a clear data sharing policy which will enable the data it generates to be more widely shared by actors in the field. It is planned that data generated within the TVS once curated and published against will be available in the next project year.
COVID mitigation in our dissemination activities has seen a move to online content including videos and blogs aimed at stakeholders as well as significant activity on social media and the website. To date 22 peer reviewed publications have been published. In addition to this significant work has been put into developing a clear and structured Public Patient Involvement and Engagement strategy and implementation plan.
MOBILISE-D is building an all-encompassing, clinically-valid digital mobility assessment system uniformly applicable across conditions where measures of mobility loss can be related to disease progression.
MOBILISE-D will contribute to the definition of mobility parameters that could be used as a new endpoint for clinical trials in drug development. It will also provide a better way to classify patients according to their disabilities, helping the process of patient stratification.
MOBILISE-D will extend the data management platform into mobility assessment, with systems developed to standards agreed with regulators and established as a new international basis for disease-specific and cross-condition endpoints
Within the first year of the project algorithms have been identified and analysed against pre-existing data to look at functionality and performance against expected DMOs.
A bespoke data management platform has been implemented and tested. Significant work has also been undertaken to standardise data for input and storage. In addition, Gold Standard methods have been developed that enable sensors to be tested against this standard.
Significant advancement has been made in regulatory approach which will have a wider impact than just Mobilise-D and will form the basis of a regulatory approach for many other digital medicine methodologies.
Mobilise-D is part of the creation of a Digital Health Catalyst that we see the development of early career researchers into the experts of tomorrow in the field of Digital Medicine.
Mobilise-D Kick Off meeting