排斥性数据,包容性呼吁:艾滋病毒预防临床试验中的性别和公平
Jason V D'Amours1, Miranda R Waggoner2
1Florida State University, Tallahassee, FL, USA.
Social studies of science
|June 27, 2025
概括
在临床试验中实现多元化的代表性仍然具有挑战性. 德斯科维的案例凸显了药物批准中的数据公平和获取公平之间的紧张关系,强调了在研究中需要考虑"公平-时间性".
科学领域:
- 临床试验的设计和监管.
- 制药药物的药物开发.
- 卫生公平和社会正义.
背景情况:
- 当代临床试验面临着对参与者代表性多样化的期望.
- 在临床研究中实现充分的人口代表性仍然是一个重大挑战.
- 药物批准的监管决策因人口统计数据有限的研究而复杂化.
研究的目的:
- 分析围绕临床试验设计中包括和排除人群的辩论.
- 检查如何不同的公平概念 (数据与访问) 在药物批准过程中造成紧张.
- 在临床研究和监管环境中引入"公平-时间性"的概念.
主要方法:
- 关于预防艾滋病毒药物Descovy的监管讨论的分析.
- 在临床试验中利用科学和技术研究对认识论框架的研究.
- 检查关于性别和药品批准研究实践的演讲冲突.
主要成果:
- 迪斯科维案例说明了一场关于在临床研究中纳入人口统计数据的有争议的辩论.
- 在确保数据收集的公平性和药物获取的公平性之间出现了紧张关系.
- 话语冲突揭示了公平的一个被低估的方面:知识生产中的时间性.
结论:
- 德斯科维的案例强调了在临床试验中实现多元化代表性的复杂性.
- 临床研究和监管中的公平概念化需要仔细考虑数据和访问.
- "公平-时间性"是理解21世纪药品批准的知识生产和社会正义的关键因素.
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