ReviewTrials2017
Specific barriers to the conduct of randomised clinical trials on medical devices.
Review in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 6 of them syntheses 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
46 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system.Journal of robotic surgery · 2026Pooled it
- Synthesis of the clinical utilities and issues of intraoperative imaging devices in clinical reports: a systematic review and thematic synthesis.BMC medical informatics and decision making · 2025Pooled it
- Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.European journal of obstetrics, gynecology, and reproductive biology · 2021Pooled it
- Pooled it
- Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review.Trials · 2018Pooled it
- Pooled it
- Immediate Effects of Mobile Phone App for Depressed Mood in Young Adults with Subthreshold Depression: A Pilot Randomized Controlled Trial.Neuropsychiatric disease and treatment · 2023Trial
- Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial.BMC cancer · 2021Trial
- Trial
- Ethics in prehospital extracorporeal cardiopulmonary resuscitation.Resuscitation plus · 2026Article
- Cost-Effectiveness of 3D-Printed Patient-Specific Versus Off-the-Shelf Interbody Cages in Lumbar Spinal Fusion: A Markov Model Cost-Utility Analysis.Journal of market access & health policy · 2026Article
- Efficacy of a video-viewing intervention of smartphone-based positive word stimulation on depressive symptoms in individuals with subthreshold depression: Protocol for a randomized controlled trial.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Health Technology Assessment in the Early Phases of Development of Medical Devices: A Catalyst for Sustainable Growth and Innovation.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2025Article
- Clinical Outcomes of 3D-Printed Titanium Patient-Specific Implants in Lumbar Interbody Fusion: A Prospective Clinical Trial with a Systematic Review of Conventional Techniques.Journal of personalized medicine · 2025Article
- Mind the (research) gap: a retrospective observational study on the utilization of new medical technologies and related research activities in German hospitals.Health research policy and systems · 2025Observational
- Article
- Characterization of medical device randomized controlled trials with adaptive designs.Journal of comparative effectiveness research · 2025Article
- Quantifying stakeholders' preference for implantable medical devices in China: a discrete choice experiment.International journal of technology assessment in health care · 2024Article
- Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.Orphanet journal of rare diseases · 2023Review
- Development of Smart Clothing to Prevent Pressure Injuries in Bedridden Persons and/or with Severely Impaired Mobility: 4NoPressure Research Protocol.Healthcare (Basel, Switzerland) · 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
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMedical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices.
methodsSystematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.
resultsIn addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency.
conclusionsThe present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.
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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.