ReviewContemporary clinical trials communications2022
Design and analysis of crossover trials for investigating high-risk medical devices: A review.
Review in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis 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
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- Novel measures of cognition and function for the AD spectrum in the Novel Measures for Alzheimer's Disease Prevention Trials (NoMAD) project: Psychometric properties, convergent validation, and contrasts with established measures.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Article
- Smart Tattoo Sensors 2.0: A Ten-Year Progress Report through a Narrative Review.Bioengineering (Basel, Switzerland) · 2024Review
- Comparison of Treatment Modality Crossovers in Telehealth and In-Person Behavioral Health Treatment in Rural Communities.Telemedicine journal and e-health : the official journal of the American Telemedicine Association · 2024Article
- Evidence from clinical trials on high-risk medical devices in children: a scoping review.Pediatric research · 2024Article
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
During evaluation of new investigational medical devices, the FDA recommends that investigators design a crossover clinical trial, in which the patients are arranged to cross over from one treatment arm to another. The FDA annually receives the premarket applications of investigational medical devices, in which sponsors design and conduct crossover trials as their confirmatory clinical trials for evaluating safety and effectiveness of the devices. This article reviews the use of crossover clinical trial in pivotal clinical trials for high-risk medical devices regulated and approved by the United States Food and Drug Administration (FDA) from 2005 to 2018. As an example, in which a crossover trial was implemented during the regulatory approval process of a new device, the article additionally presents the FDA-approved premarket approval (PMA) submission of the Medtronic MiniMed 530G system, an artificial pancreas device system that mimic a normally functioning pancreas by monitoring glucose levels and administering insulin at a certain threshold maintained by sensing blood glucose levels. The article also reiterates the critical regulatory considerations that the FDA made regarding the design and analysis of crossover trials in its guidance for industry.
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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.