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Characteristics and Results of Pediatric Medical Device Studies: 2017-2022
Sabrina Quazi1, Claire Narang2, Juan C Espinoza3
1Faculty of Medicine, University of Queensland, Queensland, Australia.
Insights
Research on pediatric medical devices is limited. A review of clinical trials found that few studies report results, highlighting a need for better trial design and faster publication of findings for children's devices.
Area of Science:
- Medical device development
- Pediatric clinical research
- Regulatory science
Background:
- Developing medical devices for children presents unique challenges, leading to a scarcity of specifically designed and tested pediatric devices.
- Understanding research activities in pediatric device development is crucial for optimizing study design and ensuring prompt clinical findings dissemination.
Purpose of the Study:
- To analyze the landscape of interventional studies for Food and Drug Administration (FDA)-regulated medical devices involving pediatric patients.
- To assess the reporting of results from completed pediatric device studies in peer-reviewed publications.
Main Methods:
- A cross-sectional analysis of interventional studies registered on ClinicalTrials.gov (2017-2022) involving FDA-regulated class II or III devices and pediatric participants (≤17 years).
- Extracted data on study characteristics and device features; determined publication status of completed studies as of December 2022.
Main Results:
- Of 482 studies, most focused on class II devices (84.2%), with common types including diabetes (11.8%) and monitoring devices (8.1%).
- The majority were single-center (67.6%), nonrandomized (52.9%), open-label (72.6%) studies, primarily funded by academia (57.7%) or industry (29.5%).
- Only 21.8% of completed studies had results published in peer-reviewed literature after a median follow-up of 3.0 years.
Conclusions:
- Findings underscore the need for enhanced pediatric-specific device development initiatives.
- Emphasizes the importance of rigorous trial design and, critically, the timely dissemination of results from pediatric device studies.
Objectives:
The development of medical devices for children faces unique challenges that have contributed to a paucity of devices specifically designed and tested for children. Increased knowledge on research activities for pediatric devices can guide optimal study design and ensure timely dissemination of clinical findings.
Methods:
We performed a cross-sectional analysis of interventional studies registered on ClinicalTrials.gov, initiated January 1, 2017, through December 12, 2022, evaluating a Food and Drug Administration-regulated class II or III device, and enrolling any pediatric patients (aged ≤17 years). Data were extracted from ClinicalTrials.gov on study characteristics and from Devices@FDA on device features. For completed studies, we determined whether results were reported in a peer-reviewed publication as of December 27, 2022.
Results:
Among 482 studies, 406 (84.2%) examined a class II device and 76 (15.8%) a class III device. The most common device types were diabetes-related devices (N = 57, 11.8%) and monitors and measurement devices (N = 39, 8.1%). Most studies were single-center (N = 326, 67.6%), used a nonrandomized (N = 255, 52.9%), open label (N = 350, 72.6%) design, and were funded by academic institutions (N = 278, 57.7%) or industry (N = 142, 29.5%). A total of 291 (60.4%) studies included a primary outcome of only efficacy without safety endpoints. Among completed studies, more than half (N = 64, 51.6%) enrolled <50 participants and 71.0% (N = 88) <100. After median follow-up of 3.0 years, results were available in publications for 27 (21.8%) completed studies.
Conclusions:
Our findings serve to inform programs and initiatives seeking to increase pediatric-specific device development. In addition to considerations on ensuring rigorous trial design, greater focus is needed on timely dissemination of results generated in pediatric device studies.
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