建立一项协议,以增加种族/民族代表性不足的少数群体在活性辐射瘤学多中心随机临床试验中的入学率
Ulysses G Gardner1, Otis W Brawley2, Elizabeth E Obi3
1Department of Radiation Oncology and Molecular Sciences.
American journal of clinical oncology
|February 11, 2025
概括
临床试验的多样性对于可概括的结果至关重要. 该议定书针对少数群体在SPORTSMEN试验中的入学障碍,旨在促进癌症研究中的公平代表性.
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:
- 代表性不足的种族/种族群体在美国临床试验中的入学人数有限,导致结果无法对不同人群进行概括.
- 少数民族入学障碍包括缺乏意识,获取问题,财务负担,对医疗系统的不信任以及医生和患者之间的人口差异.
研究的目的:
- 提出一个旨在积极增加少数群体患者在脊柱患者症状转移性新生体 (SPORTSMEN) 临床试验 (NCT05617716) 的最佳放射性手术治疗中注册的协议.
- 解决关键目标,以加强少数群体参与一个随机的,II期临床试验的症状脊柱转移.
主要方法:
- 这项研究包括有症状脊柱转移的成年患者.
- 详细说明了一项协议,以尽量减少少数群体入学障碍,重点关注五个关键领域:临床试验设计,获得护理,财务毒性,社区参与和以患者为中心的护理.
- 将收集包括种族/种族在内的基线人口统计数据,用于统计分析.
主要成果:
- 该协议旨在在SPORTSMEN临床试验中实现一致的种族/民族代表性.
- 专注于以患者为中心的策略,以克服各种人群的入学障碍.
结论:
- 增加临床试验的多样性对于产生适用于所有人口群体的强有力的证据至关重要.
- 以患者为中心的方法对于在随机临床试验中实现公平的种族/民族代表至关重要.
- 该议定书为改善少数群体参与癌症临床试验提供了一个框架.
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