ReviewClinical and translational science2023
Digital health technology derived measures: Biomarkers or clinical outcome assessments?
Review in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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
20 citing papers in PubMed.
- A Head-to-Head Comparison of Three Literature Algorithms for Physical Activity Endpoints from a Wrist Accelerometer in Free-Living Conditions.Sensors (Basel, Switzerland) · 2026Article
- A framework of digital biomarkers for neurodegenerative diseases.Nature reviews bioengineering · 2026Article
- Artificial intelligence-based biomarkers for the diagnosis and treatment of neurological conditions: a narrative review.Molecular brain · 2026Review
- Beyond symptoms: wearable digital biomarkers for subclinical detection of chemotherapy-induced peripheral neuropathy.Frontiers in oncology · 2026Article
- Remote Therapeutic Monitoring in Musculoskeletal Pain Medicine: A Systematic Review and Comparison with Remote Physiologic Monitoring.Journal of pain research · 2026Review
- Advancing the Integration of Digital Health Technologies in the Drug Development Ecosystem.Journal of medical Internet research · 2025Article
- Harnessing AI and Quantum Computing for Revolutionizing Drug Discovery and Approval Processes: Case Example for Collagen Toxicity.JMIR bioinformatics and biotechnology · 2025Article
- Developing digital health technologies for frontotemporal degeneration.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development.NPJ digital medicine · 2025Article
- Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors.Clinical pharmacology and therapeutics · 2025Review
- Aligning with regulatory agencies for the use of digital health technologies in drug development: a case study from Parkinson's disease.Frontiers in digital health · 2025Review
- Evidentiary basis of the first regulatory qualification of a digital primary efficacy endpoint.Scientific reports · 2024Article
- Implementing sensor-based digital health technologies in clinical trials: Key considerations from the eCOA Consortium.Clinical and translational science · 2024Review
- Unleashing the full potential of digital outcome measures in clinical trials: eight questions that need attention.BMC medicine · 2024Review
- Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance.NPJ digital medicine · 2024Review
- Validation framework forFrontiers in toxicology · 2024Review
- A proposed multi-domain, digital model for capturing functional status and health-related quality of life in oncology.Clinical and translational science · 2024Review
- Considering and understanding developmental and deployment barriers for wearable technologies in neurosciences.Frontiers in neuroscience · 2024Article
- Digital health technology derived measures: Biomarkers or clinical outcome assessments?Clinical and translational science · 2023Review
- The intersection of digital health and artificial intelligence: Clearing the cloud of uncertainty.Digital healthArticle
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
Digital health technologies (DHTs) present unique opportunities for clinical evidence generation but pose certain challenges. These challenges stem, in part, from existing definitions of drug development tools, which were not created with DHT-derived measures in mind. DHT-derived measures can be leveraged as either clinical outcome assessments (COAs) or as biomarkers since they share properties with both categories of drug development tools. Examples from the literature indicate a variety of applications for DHT-derived data, including capturing disease physiology, symptom tracking, or response to therapies. The distinction between the categorization of DHT-derived measures as COAs or as biomarkers can be very fine, with terminology variability among regulatory authorities. This has significant implications for integration of DHT-derived measures in clinical trials, leading to confusion regarding the evidence required to support these tools' use in drug development. There is a need to amend definitions and create clear evidentiary requirements to support broad adoption of these new and innovative tools. The biopharma industry, the technology sector, consulting businesses, academic researchers, and regulators need a dialogue via multi-stakeholder collaborations to clarify questions around DHT-derived measures, to unify definitions, and to create the foundations for evidentiary package requirements, providing a path forward to predictable results.
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What OpenQuestion holds
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.