什么时候一个团队开始讨论早期临床试验中的包容性和多样性?
Sheila Mathias1, Matthew Barnes1
1Virpax Pharmaceuticals, Philadelphia, Pennsylvania.
Clinical therapeutics
|October 17, 2025
概括
临床试验需要更早的多样性,以确保新药对所有人群都是安全有效的. 在早期阶段 (第一阶段和第二阶段) 包括多样化的参与者对于公平的医疗保健结果至关重要.
科学领域:
- 药物开发 药物开发
- 临床试验 临床试验
- 健康 公平 卫生 公平
背景情况:
- 与现有治疗方法相比,临床试验对于评估药物安全性,疗效和副作用概况至关重要.
- 新疗法旨在改善患者的生活质量,特别是对于以前无法治疗的疾病或提供更好的替代方案.
研究的目的:
- 强调将多样性纳入早期临床试验 (I期和II期) 的必要性.
- 倡导在药物开发研究中更广泛地纳入种族和民族少数群体和妇女.
主要方法:
- 分析少数群体在早期临床试验中的代表性不足.
- 将美国普通人口的人口结构与临床试验参与率进行比较.
- 在试验设计中强调不同人群中生活经验和暴露的重要性.
主要成果:
- 拉丁裔和黑人人口在美国一般人口中的代表性和他们在早期试验中的参与之间存在显著的差异.
- 在2023年,拉丁裔和黑人个体在早期阶段试验中代表性不足 (分别为6.9%和7.1%),相比于其人口份额 (18.7%和12.1%).
- 承认各种背景可以影响疾病经验,需要在所有社区探索这些差异.
结论:
- 呼吁在临床研究中早些时候就多样性纳入问题进行合作和讨论.
- 鼓励关键的意见领袖和研究人员超越仅在关键 (第三阶段) 试验中包括多样性.
- 促进探索解决方案,将多样性纳入早期药物开发阶段.
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