R指数:一种标准化的代表性指标,用于对生物制药临床试验开发中的多样性,公平性和包容性进行基准测试
Spencer L James1,2, Max Bourgognon3,4, Patricia Pinto Vieira3,4
1Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
EClinicalMedicine
|February 19, 2025
概括
一个新的R指数指标跟踪临床试验中的多样性. 这种可访问的统计数据有助于对制药药物开发和包容性研究中的代表性进行比较.
科学领域:
- 临床试验的多样性和包容性
- 制药药物开发领域的药物开发.
- 卫生公平研究 卫生公平研究
背景情况:
- 从历史上看,种族,民族和相关概念在临床试验中代表性不足.
- 监管机构,支付机构和患者倡导团体越来越多地关注制药药物开发中的多样性.
- 在临床试验中需要总结统计指标来评估代表性.
研究的目的:
- 开发一个总结的统计指标来评估临床试验中患者队列的代表性.
- 为追踪和比较研究中的多样性创建可解释和可访问的统计数据.
主要方法:
- 提出了一个统计指标,R指数,使用从绩效指标中得出的人口统计参数.
- 使用模拟数据证明了R指数,并发表了来自英国的临床试验结果.
- 从L1规范 (曼哈顿距离) 推导出R指数,并将其规范化为最大的理论误差.
主要成果:
- 该R指数表现出了理想的品质,包括一个范围为0-1,易于计算和可解释性.
- 该措施是灵活的,可以适应不同的人口框架和本体学.
- 模拟显示了R指数在评估代表性的有用性.
结论:
- R指数是一种可解释和可访问的总结统计数据,用于追踪和对比包容性研究中的代表性.
- R指数可以适应各种人口框架和本体学,使其适用于不同的研究环境.
- 这一措施可以帮助改善临床试验开发中的多样性和包容性.
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