与年龄相关的黄斑变性临床试验的入学特征:一个横截面研究
Brendan K Tao1, Jim S Xie2, Victoria Leung3
1Faculty of Medicine, The University of British Columbia, 317-2194 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada.
Eye (London, England)
|December 28, 2024
概括
在与年龄相关的黄斑变性 (AMD) 试验中,女性的入学率反映了疾病的患病率,但种族和种族数据往往缺失. 未来的研究需要公平的招生策略,以改善临床研究的多样性.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 人口统计数据 人口统计数据
背景情况:
- 与年龄相关的黄斑变性 (AMD) 不成比例地影响某些人群.
- 确保临床试验中的多样化代表性对于研究结果的概括性至关重要.
- 之前的研究已经强调了临床试验招生中的潜在差异.
研究的目的:
- 调查与年龄相关的黄斑变性 (AMD) 临床试验中的人口学招生特征.
- 评估在 AMD 试验中女性,种族和族群代表性的公平性.
- 识别与人口统计学入学模式相关的试验特征.
主要方法:
- 在ClinicalTrials.gov的系统搜索中,发现了106个针对AMD的随机对照试验 (RCT).
- 收集了患者人口统计数据和试验特征 (阶段,掩护,位置,赞助商).
- 计算了女性人口与流行率 (PPR),并与公平入学基准 (0.8-1.2) 进行了比较.
主要成果:
- 总共有77,939名患者被纳入,其中46.3%是女性;聚合的女性PPR为0.88.
- 在大多数试验特征中观察到平等的女性入学率,对四重失明和早期试验阶段的不确的发现.
- 在大多数试验中,种族和种族的报道不足,白人参与者是代表性最大的群体.
结论:
- 在AMD试验中的女性参与通常与疾病患病率保持一致.
- 种族和种族数据的显著报告不足限制了对试验多样性的理解.
- 未来的AMD试验必须优先考虑公平的招生策略和全面的人口统计数据收集.
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