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相关概念视频

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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
PubMed
概括
此摘要是机器生成的。

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).

关键词:
临床试验多样性,公平,包容性和归属性患者招募种族和民族少数群体

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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.