ArticleDigital biomarkers
Quantifying the Benefits of Digital Biomarkers and Technology-Based Study Endpoints in Clinical Trials: Project Moneyball.
Article in Digital biomarkers. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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.
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Who cites it
12 citing papers in PubMed.
- Powering Neurology Drug Development Trials to Reduce False Negative Results.Clinical and translational science · 2026Review
- Challenges and potential of using digital biomarkers in healthcare and clinical trials.Communications medicine · 2026Review
- Wearable sensors in paediatric neurology.Developmental medicine and child neurology · 2025Review
- Wearable-Based Kinematic Analysis of Upper-Limb Movements During Daily Activities Could Provide Insights into Stroke Survivors' Motor Ability.Neurorehabilitation and neural repair · 2024Article
- Assessing the net financial benefits of employing digital endpoints in clinical trials.Clinical and translational science · 2024Article
- A novel machine learning based framework for developing composite digital biomarkers of disease progression.Frontiers in digital health · 2024Article
- Impacts on study design when implementing digital measures in Parkinson's disease-modifying therapy trials.Frontiers in digital health · 2024Article
- Modeling of Parkinson's Disease Progression and Implications for Detection of Disease Modification in Treatment Trials.Journal of Parkinson's disease · 2024Article
- Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract.JMIR research protocols · 2023Article
- Digital health technology derived measures: Biomarkers or clinical outcome assessments?Clinical and translational science · 2023Review
- Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies.Clinical and translational science · 2023Review
- Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST.Digital biomarkersArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Digital biomarkers have significant potential to transform drug development, but only a few have contributed meaningfully to bring new treatments to market. There are uncertainties in how they will generate quantifiable benefits in clinical trial performance and ultimately to the chances of phase 3 success. Here we have proposed a statistical framework and ran a proof-of-concept model with hypothetical digital biomarkers and visualized them in a familiar manner to study power calculation. Methods: A Monte Carlo simulation for Parkinson's disease (PD) was performed using the Captario SUM® platform and illustrative study technology impact calculations were generated. We took inspiration from the EMA-qualified wearable-derived digital endpoint stride velocity 95 Results: Four scenarios with different combinations of technologies were illustrated. The model illustrated a way to quantify the magnitude of the contributions that enrichment and endpoint technologies could make to drug development studies. Discussion/Conclusion: Quantitative models could be valuable not only for the study sponsors but also as an interactive and collaborative engagement tool for technology players and multi-stakeholder consortia. Establishing values of digital biomarkers could also facilitate business cases and financial investments.
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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.