ArticleSensors (Basel, Switzerland)2020
Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson's Patients Using Digital Mobility Outcomes.
Article in Sensors (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Digital Outcomes as Biomarkers of Disease Progression in Early Parkinson's Disease: A Systematic Review.Movement disorders : official journal of the Movement Disorder Society · 2025Pooled it
- Associations of insulin-like growth factor-1 with gait vigor, symmetry, and stability metrics measured by wearable sensors in older adults.BMC geriatrics · 2026Article
- From phenotype to biology: a multi-modal roadmap of biofluid, tissue, imaging, and digital biomarkers in Parkinson's disease.Translational neurodegeneration · 2026Review
- A systematic review of real-world gait-related digital mobility outcomes in Parkinson's disease.NPJ digital medicine · 2025Article
- Regulatory considerations for developing remote measurement technologies for Alzheimer's disease research.NPJ digital medicine · 2024Article
- Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers.Cerebellum (London, England) · 2024Review
- Improved measurement of disease progression in people living with early Parkinson's disease using digital health technologies.Communications medicine · 2024Article
- Mobilise-D insights to estimate real-world walking speed in multiple conditions with a wearable device.Scientific reports · 2024Article
- Enhancing public health in developing nations through smartphone-based motor assessment.Frontiers in digital health · 2024Article
- Digital technologies: Innovations that transform the face of drug development.Clinical and translational science · 2023Review
- Digital health technology derived measures: Biomarkers or clinical outcome assessments?Clinical and translational science · 2023Review
- Assessing real-world gait with digital technology? Validation, insights and recommendations from the Mobilise-D consortium.Journal of neuroengineering and rehabilitation · 2023Article
- Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies.Clinical and translational science · 2023Review
- Mobility recorded by wearable devices and gold standards: the Mobilise-D procedure for data standardization.Scientific data · 2023Article
- Digital endpoints in clinical trials of Alzheimer's disease and other neurodegenerative diseases: challenges and opportunities.Frontiers in neurology · 2023Review
- Ecological validity of a deep learning algorithm to detect gait events from real-life walking bouts in mobility-limiting diseases.Frontiers in neurology · 2023Article
- A multi-sensor wearable system for the assessment of diseased gait in real-world conditions.Frontiers in bioengineering and biotechnology · 2023Article
- Association between heart failure severity and mobility in geriatric patients: an in-clinic study with wearable sensors.Journal of geriatric cardiology : JGC · 2022Article
- What contributes most to the SPPB and its subscores in hospitalized geriatric patients: an ICF model-based approach.BMC geriatrics · 2022Article
- Healthcare Providers' Knowledge of Value-Based Care in Germany: An Adapted, Mixed-Methods Approach.International journal of environmental research and public health · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Wearable inertial sensors can be used to monitor mobility in real-world settings over extended periods. Although these technologies are widely used in human movement research, they have not yet been qualified by drug regulatory agencies for their use in regulatory drug trials. This is because the first generation of these sensors was unreliable when used on slow-walking subjects. However, intense research in this area is now offering a new generation of algorithms to quantify Digital Mobility Outcomes so accurate they may be considered as biomarkers in regulatory drug trials. This perspective paper summarises the work in the Mobilise-D consortium around the regulatory qualification of the use of wearable sensors to quantify real-world mobility performance in patients affected by Parkinson's Disease. The paper describes the qualification strategy and both the technical and clinical validation plans, which have recently received highly supportive qualification advice from the European Medicines Agency. The scope is to provide detailed guidance for the preparation of similar qualification submissions to broaden the use of real-world mobility assessment in regulatory drug trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.