Evidence from clinical trials on high-risk medical devices in children: a scoping review

Guerlich, Kathrin, Patro-Golab, Bernadeta, Dworakowski, Paulina, Fraser, Alan G., Kammermeier, Michael, Melvin, Tom and Koletzko, Berthold 2024. Evidence from clinical trials on high-risk medical devices in children: a scoping review. Pediatric Research 95 , pp. 615-624. 10.1038/s41390-023-02819-4

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Abstract

Background Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. Methods Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0–21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022. Results From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. Conclusion Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Springer Nature [academic journals on nature.com]
ISSN:	0031-3998
Date of First Compliant Deposit:	20 October 2023
Date of Acceptance:	3 September 2023
Last Modified:	15 Apr 2024 13:31
URI:	https://orca.cardiff.ac.uk/id/eprint/163350

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