从瘤学临床试验中排除基于功能状态的患者
Nicole D Agaronnik1, Mary Linton B Peters2,3, Lisa I Iezzoni3,4
1Harvard Medical School, Boston, MA, USA.
Clinical trials (London, England)
|January 2, 2025
概括
由于严格的绩效状况标准,残疾人面临癌症临床试验的排除. 目前的试验通常使用比拟的FDA指南更具限制的资格,限制了这一群体的获取.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
- 健康 公平 卫生 公平
背景情况:
- 与没有残疾的人相比,残疾人患癌症 (不包括皮肤癌) 的比例更高.
- 美国食品和药物管理局 (FDA) 正考虑更新指南 (2024年),以减轻临床试验资格的绩效状况标准.
- 基于绩效状况和其他标准的残疾排除在临床试验中需要审查.
研究的目的:
- 调查残疾人被排除在瘤学临床试验之外的情况.
- 评估当前临床试验中的性能状态标准的限制性.
- 将试验资格标准与FDA指南草案进行比较.
主要方法:
- 在ClinicalTrials.gov (2019-2023) 上列出的96个干预性瘤临床试验的第三期和第四期资格标准进行了审查.
- 使用东部合作性瘤学集团 (ECOG) 绩效状态尺度和卡诺夫斯基绩效尺度 (KPS) 评估功能状态值.
- 对与功能障碍或残疾相关的标准进行了定性分析.
主要成果:
- 大约40%的试验具有限制性的ECOG (0-1) 或KPS (≥70) 值.
- 只有20%的试验包括ECOG 2或KPS 60的患者.
- 许多试验具有未指定的标准,可能会排除残疾人;没有注意到任何住宿条件.
结论:
- 瘤学试验经常排除具有比FDA指导方针草案建议的更具限制性的绩效状况得分的个体.
- 除了绩效状态之外,现有的试验标准也可能无意中排除残疾人.
- 调查结果提供了基线数据,以评估2024年潜在的FDA指南对未来试验中残疾人纳入问题的影响.
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