有多少残疾儿童参与临床试验? 一个范围审查
Guido Camanni1, Ornella Ciccone, Alessandro Lepri
1Istituto Serafico di Assisi, Viale Guglielmo Marconi, 6, 06081 Assisi, Perugia, Italy, guidocamanni@serafico.it.
Psychiatria Danubina
|November 23, 2023
概括
残疾儿童经常被排除在临床试验之外. 这项研究发现,超过一半的试验具有明确或隐含的排除标准,突出了对更具包容性的研究实践的需求.
科学领域:
- 医学研究 医学研究
- 临床试验中的临床试验.
- 关于残疾人的研究.
背景情况:
- 残疾儿童 (CWDs) 面临着参与科学研究的重大障碍.
- 缺乏关于CWD从临床试验中排除率的准确数据.
- 这项研究旨在量化CWD被排除在最近的医学研究之外的情况.
研究的目的:
- 评估残疾儿童被排除在临床试验中的排斥率.
- 确定医学研究中使用的明确和隐含排除标准.
- 评估CWDs的排除标准的适当性.
主要方法:
- 在Clinicaltrials.gov (2010-2020) 注册的干预性临床试验的范围审查.
- 分析的重点是与全球残疾调整寿命年 (DALYs) 的前十大原因相关的试验.
- 排斥标准的分类是明确的 (与残疾相关) 或隐含的 (模糊).
主要成果:
- 分析了328项试验,58.8%的试验至少有一个对慢性损伤患者的明确或隐含排除标准.
- 行为或精神疾病是最常被排除的残疾类别 (56.1%).
- 在46.6%的试验中存在隐性排除标准,这表明广泛的排除潜力.
结论:
- 观察到,残疾儿童从临床试验中被排除在外的比例很高.
- 对于长期残疾人,有必要制定包容性研究设计和适应性策略.
- 促进CWD参与对于公平的医疗进步至关重要.
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