新生儿不良事件严重程度尺度:当前情况,利益相关方的评估,以及未来的前景
Karel Allegaert1,2,3, Thomas Salaets1,4, Kelly Wade5
1Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Frontiers in pediatrics
|January 23, 2024
概括
新生儿不良事件严重程度尺度 (NAESS) 提供了一个标准化工具,用于评估新生儿临床试验中的不良事件. 它的开发和验证旨在提高数据的一致性,并支持明智的治疗决策.
科学领域:
- 新生儿临床试验 新生儿临床试验
- 药物安全性和疗效评估药物安全性和疗效评估
- 医疗器械开发 医疗器械开发
背景情况:
- 标准化工具对于可重现的临床试验结果和治疗干预措施的比较分析至关重要.
- 评估不良事件的严重性,因果关系和严重程度对于药物安全性评估至关重要.
- 国际新生儿联盟 (INC) 开发了新生儿不良事件严重程度尺度 (NAESS),作为全面评估工具箱的一部分.
研究的目的:
- 报告新生儿不良事件严重程度尺度 (NAESS) 的开发,验证和影响.
- 评估利益相关者对NAESS工具的相关性和未来发展的观点.
- 突出NAESS在支持药物注册和处方决策中的作用.
主要方法:
- 最初的NAESS版本由INC开发.
- 在回顾性和前性临床试验中NAESS的验证.
- 在监管文件,试验协议和监管机构,赞助商和研究人员的研究报告中分析NAESS的使用情况.
主要成果:
- 该NAESS尺度经过了验证,证明了其适用性和对新生儿试验中观察者间变异性的影响.
- 利益相关者在各种临床试验文档中报告了NAESS的使用情况.
- 该工具已被监管机构,赞助商和学术研究人员利用.
结论:
- 在标准化对新生儿群体不良事件的评估方面,NAESS工具已被证明是有用的.
- 进一步开发NAESS被认为可以提高其在临床实践和研究中的实用性.
- 美国国家药物安全和疗效研究中心 (NAESS) 帮助制定有关新生儿药物安全和疗效的明智决策.
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