ReviewNPJ digital medicine2023
Evolving regulatory perspectives on digital health technologies for medicinal product development.
Review in NPJ digital medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed, 50 citations in OpenAlex.
- How Digital Health Technologies have been Used to Support Regulatory Drug Approval.Therapeutic innovation & regulatory science · 2026Article
- Frameworks for Guiding the Selection of Digital Data Collection Tools Used in Clinical Trials: Protocol for a Systematic Review.JMIR research protocols · 2026Article
- Understanding digital inclusion through the transformation of services and users: a narrative review and novel framework.BMJ digital health & AI · 2026Review
- Wearable sensors in paediatric neurology.Developmental medicine and child neurology · 2025Review
- Success factors and measures for scaling patient-facing digital health technologies from leaders' insights.BMC health services research · 2025Article
- V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.NPJ digital medicine · 2025Review
- Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU-summary of a Focus group discussion.Frontiers in medicine · 2025Article
- Designing and developing a prescription digital therapeutic for at-home heart rate variability biofeedback to support and enhance patient outcomes in post-traumatic stress disorder treatment.Frontiers in digital health · 2025Article
- Regulatory considerations for developing remote measurement technologies for Alzheimer's disease research.NPJ digital medicine · 2024Article
- In-Clinic and Natural Gait Observations master protocol (I-CAN-GO) to validate gait using a lumbar accelerometer.Scientific reports · 2024Article
- Digital health in stroke: a narrative review.Arquivos de neuro-psiquiatria · 2024Review
- Assessing the net financial benefits of employing digital endpoints in clinical trials.Clinical and translational science · 2024Article
- The Revolution of Digital Therapeutics (DTx) in the Pharmaceutical Industry and Their Quality Impacts.Cureus · 2024Review
- Disease-Agnostic Electronic Adherence Aid for Subcutaneous at-Home and Self-Administration Devices-The Lowest Common Denominator Based on a Cross-Indication Survey.ACS pharmacology & translational science · 2024Article
- Improved measurement of disease progression in people living with early Parkinson's disease using digital health technologies.Communications medicine · 2024Article
- Use of smartphone-based remote assessments of multiple sclerosis in Floodlight Open, a global, prospective, open-access study.Scientific reports · 2024Article
- Digitalization of toxicology: improving preclinical to clinical translation.Frontiers in toxicology · 2024Article
- Digital Medical Information Services Delivered by Pharmaceutical Companies via WeChat: Qualitative Analytical Study.Journal of medical Internet research · 2023Article
- Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract.JMIR research protocols · 2023Article
- Incorporating digitally derived endpoints within clinical development programs by leveraging prior work.NPJ digital medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Digital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and minimising risk in medicines development. This review is comprised of four case studies of DHTTs used throughout the lifecycle of medicinal products, starting from their development. These cases illustrate how the regulatory requirements of DHTTs used in medicines development are based on two European regulatory frameworks (medical device and the medicinal product regulations) and highlight the need for increased collaboration between various stakeholders, including regulators (medicines regulators and device bodies), pharmaceutical sponsors, manufacturers of devices and software, and academia. As illustrated in the examples, the complexity of the interactions is further increased by unique challenges related to DHTTs. These case studies are the main examples of DHTTs with a regulatory assessment thus far, providing an insight into the applicable current regulatory approach; they were selected by a group of authors, including regulatory specialists from pharmaceutical sponsors, technology experts, academic researchers and employees of the European Medicines Agency. For each case study, the challenges faced by sponsors and proposed potential solutions are discussed, and the benefit of a structured interaction among the different stakeholders is also highlighted.
Identifiers
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.