慢性乙型肝炎随机对照试验中的多样性和包容性:一个系统的元流行病学审查
Xintong Huang1,2, Angela C Webster1,2,3, Shiva R Mishra1,3
1National Health and Medical Research Council Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
JHEP reports : innovation in hepatology
|March 27, 2025
概括
慢性乙型肝炎 (CHB) 临床试验缺乏多样性,女性和非洲人群的代表性不足. 需要更多的包容性,以确保治疗有利于所有受影响的个体.
科学领域:
- 肝病学和临床试验方法学
- 公共卫生和流行病学
背景情况:
- 慢性乙型肝炎 (CHB) 的患病率和疾病进展在全球范围内各不相同.
- 临床试验设计必须平衡科学严谨性与公平的患者代表性.
- 确保CHB试验中多样化的参与者群体对于有效的公共卫生干预至关重要.
研究的目的:
- 评估CHB随机对照试验中的多样性和包容性.
- 评估CHB临床试验中人口特征的报告和表现.
- 为了确定参与者招聘和排除标准的差异.
主要方法:
- 来自MEDLINE和Embase的CHB随机对照试验 (RCT) 的超流行病学研究 (2010年1月至2023年7月).
- 提取了参与者的人口统计数据 (年龄,性别,国家,种族/民族,基因型) 和试验特征.
- 分析了人口统计报告的透明度,并将参与者人口统计数据与全球CHB人口进行了比较.
主要成果:
- 在287个CHB试验中,大多数报告的年龄和性别,但很少报告种族/种族 (37.3%) 或基因型 (29.3%).
- 观察到妇女的显著代表性不足 (28.7%的参与者与42.0%的受影响者) 和非洲人口 (0.01%与31.0%的受影响者).
- 排除标准经常限制了生殖能力和特定年龄段的妇女的参与.
结论:
- 临床试验表明,CHB的临床试验显示了显著的包容性差距,特别是在非洲的妇女和个人中.
- 研究人员,资助者和出版商急需优先考虑CHB研究中的多样性和包容性.
- 改善人口统计报告和有针对性的招聘策略对于公平的证据生成至关重要.
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