系统层面的转变,以增加患者参与临床试验
Nicole E Caston1,2, Luqin Deng3, Courtney P Williams3
1Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham (UAB), Birmingham, AL.
JCO oncology practice
|March 13, 2025
概括
癌症临床试验的修改被乳腺癌幸存者认为是有利的. 然而,来自社会脆弱地区的参与者表现出不太愿意参与修改后的试验协议,这表明需要进一步研究.
科学领域:
- 在瘤学瘤学.
- 公共卫生 公共卫生
- 医疗保健服务研究 医疗服务研究
背景情况:
- 由于COVID-19大流行,美国食品和药物管理局 (FDA) 允许对癌症临床试验进行修改.
- 政策制定者正在评估这些试验修改的延续.
- 了解患者对这些变化的影响的看法对于未来的政策决策至关重要.
研究的目的:
- 评估乳腺癌幸存者在COVID-19大流行期间对癌症临床试验的修改的观点.
- 调查县级社会脆弱性与参与修改后临床试验的意愿之间的联系.
主要方法:
- 一项横截面研究调查了573名女性乳腺癌幸存者.
- 根据试验修改 (位置,远程医疗,方便性,选择退出程序) 收集关于参与意愿的数据.
- 使用社会脆弱性指数 (SVI) 评估了县级的社会脆弱性;多项逻辑回归分析了协会.
主要成果:
- 超过一半的参与者 (53%) 非常愿意参加在家药物递送的试验.
- 在最脆弱的县 (前10%SVI) 的受访者没有表现出参与远程医疗试验的意愿 (OR,0.21 [95%CI,0.07到0.63]).
- 对于脆弱人群中的其他试验修改也观察到类似的非显著趋势.
结论:
- 乳腺癌幸存者通常对癌症临床试验的修改做出了有利的反应.
- 居住在高度社会脆弱的县的个人受到这些修改的影响较小.
- 需要进行进一步的研究,以确定可以增强弱势患者群体参与试验的修改.
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