临床试验中的代表性,准入和包容性:从ASCPT 2025患者论坛的患者为中心的观点
Stephani L Stancil1,2, Ricki Fairley3, Latoya Bolds-Johnson3
1Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USA.
Clinical pharmacology and therapeutics
|February 11, 2026
概括
临床试验的多样性仍然是一个挑战,关键人群的代表性不足阻碍了治疗创新. 来自不同利益相关者的可操作见解对于实现患者在临床研究中的公平参与至关重要.
科学领域:
- 临床药理学 临床药理学
- 治疗创新治疗创新
- 卫生公平性健康公平性
背景情况:
- 临床试验对于开发新疗法至关重要,但往往无法代表多样化的患者群体.
- 尽管有针对性的包容性努力,但妇女,少数民族和儿童的代表性仍然不足.
- 临床试验中的公平代表对于确保新疗法有利于所有人群至关重要.
研究的目的:
- 突出临床试验中代表人数不足的持续问题.
- 为改善治疗研究中的患者多样性提供实际策略.
- 介绍一个多学科小组关于加强临床试验包容性的观点.
主要方法:
- 这是一篇由美国临床药理学和治疗学患者论坛的讨论提供信息的视角文章.
- 整合了来自患者,临床医生,研究人员和患者倡导者的见解.
- 专注于公平代表的可操作策略.
主要成果:
- 确定了关键人口群体在临床试验中的持续差距.
- 收集了各种各样的利益相关者对包容性障碍和促进者的观点.
- 为改善代表性制定了可行的建议.
结论:
- 在临床试验中实现公平的代表性需要持续的,多方面的努力.
- 患者,临床医生,研究人员和倡导者之间的合作对于进步至关重要.
- 解决代表性不足问题最大限度地提高了临床试验结果的治疗影响和概括性.
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