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儿科医疗器械研究的特征和结果:2017-2022年
Sabrina Quazi1, Claire Narang2, Juan C Espinoza3
1Faculty of Medicine, University of Queensland, Queensland, Australia.
Pediatrics
|August 11, 2023
概括
对儿科医疗器械的研究是有限的. 对临床试验的审查发现,很少有研究报告结果,强调需要更好的试验设计和更快地公布儿童设备的发现.
科学领域:
- 医疗器械开发 医疗器械开发
- 儿科临床研究的临床研究.
- 监管科学是一种监管科学.
背景情况:
- 为儿童开发医疗器械面临着独特的挑战,导致专门设计和测试的儿科设备稀缺.
- 了解儿科器械开发的研究活动对于优化研究设计和确保快速传播临床发现至关重要.
研究的目的:
- 分析涉及儿科患者的食品和药物管理局 (FDA) 监管的医疗器械干预研究的情况.
- 评估在同行评审出版物中报告完成的儿科器械研究结果.
主要方法:
- 在clinicaltrials.gov (2017-2022) 注册的干预研究的横截面分析,涉及FDA监管的II或III类设备和儿科参与者 (≤17岁).
- 提取了研究特征和设备特征的数据;确定了截至2022年12月完成研究的出版状态.
主要成果:
- 在482项研究中,大多数专注于II类设备 (84.2%),其中常见的类型包括糖尿病 (11.8%) 和监测设备 (8.1%).
- 大多数是单中心 (67.6%),非随机 (52.9%),开放标签 (72.6%) 的研究,主要由学术界 (57.7%) 或工业 (29.5%) 资助.
- 在完成的研究中,只有21.8%的研究结果在经过同行评审的文献中发表,平均随访时间为3.0年.
结论:
- 这些发现强调了需要加强儿科专用设备开发计划的必要性.
- 强调严格的试验设计的重要性,并且,重要的是,及时传播儿科器械研究的结果.
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