在美国注册的玻璃眼临床试验中基于性别的差异性招生:一项横截面研究
Brendan K Tao1, Jim S Xie1, Anastasiya Vinokurtseva2
1Department of Ophthalmology & Vision Science, University of Toronto, Toronto, ON, Canada.
Seminars in ophthalmology
|August 28, 2025
概括
美国的玻璃眼临床试验显示女性患者的入学比例与疾病的患病率一致. 未来的研究应该继续确保在眼研究中参与者的多样性.
科学领域:
- 眼科 眼科
- 临床试验
- 医疗公平
背景情况:
- 玻璃眼会影响大部分人群,在不同的人口群体中患病率有所不同.
- 确保临床试验中的公平代表性对于结果的概括性至关重要.
- 之前的研究强调了某些群体在医学研究中的代表性不足.
研究的目的:
- 评估与眼相关的随机对照试验 (RCT) 中患者的性别登记.
- 将患者登记数据与现实世界眼疾病负担进行比较.
- 确定青光眼研究中的人口代表性趋势.
主要方法:
- 一项截面研究分析了在ClinicalTrials.gov上注册的直至2023年1月的玻璃眼RCT.
- 包含的试验是双重掩盖的,已完成,并已发表结果.
- 人口与患病率 (PPR) 被计算出以评估女性入学率的充分性.
主要成果:
- 在1061个记录中,包括177个试验 (N=38,475;女性56. 2%).
- 综合的女性PPR为1. 05 (95% CI为1. 02,1. 08),表明招募人数足够多.
- 在大多数研究特征中观察到平等的女性入学率,而1997年之前的研究显示不确定的数据.
结论:
- 美国注册的玻璃眼试验显示,相对于疾病负担,女性参与者的数量是可以接受的.
- 研究结果表明,在青光眼研究中,人口代表性得到了公平的发展.
- 建议继续努力,确保在未来的临床试验中招募多样性.
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