在临床试验中衡量代表性
Allen Sanyi1,2, Samuel Byiringiro3, Sanaz Dabiri4
1Department of Medicine (A.S.), Emory University School of Medicine, Atlanta, GA.
Circulation
|February 3, 2025
概括
在临床试验中衡量代表性对于公平的研究至关重要. 虽然没有单一的方法是完美的,但多方面的方法可以改善试验中的多样性,公平性,包容性和归属性 (DEIB).
科学领域:
- 临床试验
- 医疗公平
- 研究方法
背景情况:
- 临床试验的代表性对于外部有效性,公平的研究准入和公众信任至关重要.
- 量化代表性是实现临床研究多样性,公平,包容和归属 (DEIB) 的关键一步.
- 某些群体在试验中的传统代表性需要强有力的测量策略.
研究的目的:
- 探索各种定量方法来测量随机临床试验中的代表性.
- 评估不同方法评估试验参与者的人口统计数据的优缺点.
- 为利益相关者提供有关在临床研究中评估和改进DEIB的适当指标的信息.
主要方法:
- 对测量试验代表性的拟议方法的审查,包括参与率与流行率和招生分数.
- 基于利益相关者需求和试验环境的不同量化措施的有用性分析.
- 考虑使用定量代表性目标的潜在意外后果.
主要成果:
- 衡量代表性存在多种方法,每种方法都有其局限性.
- 参与率与患病率的比率对于具有明确的人口结构的试验是有用的.
- 报名比例和人口统计报告的结合提供了更细致的代表性观点.
结论:
- 在所有临床试验中,没有一种单一的方法可以全面解决DEIB问题.
- 建议采用精心设计的多方面的方法来衡量代表性.
- 经过深思熟虑的使用,定量测量可以指导提高临床试验参与多样性的努力.
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