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Evidence from clinical trials on high-risk medical devices in children: a scoping review
Kathrin Guerlich1,2, Bernadeta Patro-Golab1, Paulina Dworakowski3
1LMU-Ludwig Maximilians Universität Munich, Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, Munich, Germany.
Insights
Clinical trials for high-risk pediatric medical devices often lack concurrent controls and enroll few young children. This review highlights challenges in pediatric device research and regulatory compliance.
Area of Science:
- Medical Device Regulation
- Paediatric Medical Devices
- Clinical Trial Methodologies
Background:
- Navigating European Medical Device Regulation (EU 2017/745) poses challenges for clinical evaluation, especially for high-risk pediatric devices.
- Increased regulatory scrutiny necessitates robust clinical evidence for devices used in children.
Purpose of the Study:
- To conduct a scoping review of clinical trials for high-risk pediatric medical devices.
- To systematically summarize methodologies used in pediatric device clinical trials.
- To identify challenges in pediatric medical device research and inform regulatory requirements.
Main Methods:
- Scoping review of clinical trials investigating high-risk pediatric medical devices.
- Searched Medline and Embase databases from January 2017 to November 2022.
- Included patients aged 0-21 years across cardiology, diabetology, orthopaedics, and surgery.
Main Results:
- 99 trials were included from 1692 screened records, primarily from North America and Europe.
- Diabetology devices were most evaluated; most trials enrolled adolescents, with 39% including both children and adults.
- Randomized controlled trials comprised 38% of the sample; 64% of trials had <100 participants, and many lacked concurrent control groups.
Conclusions:
- Clinical trials for high-risk pediatric medical devices exhibit varied designs, often lack concurrent controls, and underrepresent infants and young children.
- Challenges exist in conducting adequately powered randomized controlled trials for pediatric devices.
- Findings can assist authorities in setting realistic evidence requirements for pediatric device conformity certification under new regulations.
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.
Impact:
In the assessed sample, clinical trials on high-risk medical devices in children were mainly small, with variable study designs (often without concurrent control), and they mostly enrolled adolescents. We provide a systematic summary of methodologies applied in clinical trials of medical devices in the paediatric population, reflecting obstacles in this research area that make it challenging to conduct adequately powered randomized controlled trials. In view of changing European regulations and related concerns about shortages of high-risk medical devices for children, our findings may assist competent authorities in setting realistic requirements for the evidence level to support device conformity certification.
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