区域和实践试验场所在非代表性随机癌症试验招生中的作用
Sachin J Shah1, Christopher R Manz2, Brendan Balthis1
1Center for Aging and Serious Illness and Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
Journal of the National Cancer Institute
|March 20, 2025
概括
地理位置和临床地点的选择显著影响癌症试验多样性. 多样化试验招生需要在患者转诊和招聘实践中进行战略性改变,以确保更好的代表性.
科学领域:
- 临床瘤学临床瘤学
- 医疗保健服务研究 医疗服务研究
- 健康 公平 卫生 公平
背景情况:
- 代表性临床试验对于推进癌症治疗的有效性和安全性至关重要.
- 影响癌症试验患者招募的地理和基于实践的因素仍未得到充分研究.
- 参与试验的差异可能会限制研究结果对不同患者群体的概括性.
研究的目的:
- 调查地理区域和临床实践选择对癌症药物试验招生代表性的影响.
- 量化定位决策对特定人口群体在癌症试验中未充分注册的贡献.
主要方法:
- 使用了SEER-Medicare队列65岁及以上的患者,他们被诊断患有肺癌,乳腺癌,胰腺癌或癌 (2014-2019).
- 确定了随机癌症药物试验的参与者,并分析了人口统计数据 (年龄,性别,种族,种族,农村居住地).
- 在整体队列,试验注册地区,试验注册实践和试验参与者中比较人口统计学流行率.
主要成果:
- 地理区域和实践选择占黑人,西班牙裔和农村患者未充分招募的50%以上.
- 根据比例代表,癌症试验的黑人患者数量比预期的少45%.
- 在黑人患者较少的地区招聘为这种差异贡献了27%,而实践贡献了35%.
结论:
- 选择试验注册地区和实践显著影响癌症临床试验中的患者代表性.
- 解决少数民族和农村人口的低招生问题需要对患者的转诊和招生地点和由谁转诊和招生进行战略变革.
- 多样化癌症试验需要有意识地努力修改地理和基于实践的招聘策略.
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