ReviewClinical pharmacology and therapeutics2025
Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors.
Review in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed.
- Artificial intelligence in clinical trials-state of the evidence, gaps, and next steps.EClinicalMedicine · 2026Review
- Article
- How Digital Health Technologies have been Used to Support Regulatory Drug Approval.Therapeutic innovation & regulatory science · 2026Article
- From Concept to Claim: An Integrated Lifecycle Roadmap (ILR) for Patient-Centric Endpoints in Clinical Trials and Real-World Evidence.Healthcare (Basel, Switzerland) · 2026Review
- Sensor-based digital health technologies to capture endpoints in recent clinical trials: a scoping review.NPJ digital medicine · 2026Article
- Real-world walking speed as a digital biomarker and outcome measure for clinical trials-a systematic review, regulatory status and future directions.Frontiers in digital health · 2026Review
- Developing digital health technologies for frontotemporal degeneration.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- A Hierarchical Framework for Selecting Reference Measures for the Analytical Validation of Sensor-Based Digital Health Technologies.Journal of medical Internet research · 2025Article
- V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.NPJ digital medicine · 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
- Syndication in science: Curated collaboration.Clinical and translational science · 2024Review
- Implementing sensor-based digital health technologies in clinical trials: Key considerations from the eCOA Consortium.Clinical and translational science · 2024Review
- Article
- Using Digital Outcomes to Measure Meaningful Aspects of Health in Clinical Trials for Parkinson's Disease: A Scoping Review.Digital biomarkersReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite widespread interest and substantial investment in the adoption of sensor-based digital health technologies (sDHTs) for remote data capture in drug development trials, no drug has been approved based on an sDHT-derived primary endpoint in the United States (US). One reason for this lack of advancement is the complexity of obtaining regulatory endorsement for those endpoints within current US regulatory pathways. The goal of our review is to describe the two choices currently available to pharmaceutical study Sponsors: (i) they may navigate the traditional route of compiling the evidence to support the sDHT-derived endpoint in their investigational new drug (IND) application, requiring specific expertise and substantial resources; or (ii) they may navigate the drug development tool (DDT) pathway with the goal of qualifying their sDHT-derived endpoint as a biomarker or clinical outcome assessment applicable to a broader context of use (COU), either alone or as part of a partnership or consortium. We describe the nuances of each pathway; the evidentiary requirements for supporting an sDHT-derived endpoint and the technology used to capture it; and the impact that an sDHT's regulatory status may have on a Sponsor's decision to use it for data capture. By systematically comparing the IND and DDT pathways, our over-arching goals are to support the increasing deployment of sDHTs within the clinical research setting and help advance regulatory science in the field of digital medicine.
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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.