检查DCT解决方案使用与临床试验参与者多样性之间的关联
1Tufts Center for the Study of Drug Development, Tufts University, Boston, USA. zachary.smith605922@tufts.edu.
Therapeutic innovation & regulatory science
|May 11, 2024
概括
分散临床试验 (DCT) 解决方案显示出改善临床试验多样性的前景. 当地实验室和虚拟访问与分别较低的白人和黑人参与者的百分比有关.
科学领域:
- 临床研究 临床研究
- 健康 公平 卫生 公平
- 医疗信息学 医疗信息学
背景情况:
- 事证据表明,去中心化临床试验 (DCT) 解决方案增强了参与者多样性.
- 缺乏支持DCT对多样性的影响的定量数据.
研究的目的:
- 在临床试验中量化评估DCT解决方案与参与者多样性之间的关联.
- 确定可能影响人口代表性的特定DCT组件.
主要方法:
- 分析了先前研究和clinicaltrials.gov.gov的数据.
- 在使用虚拟访问,家庭访问,设备/可穿戴设备和当地实验室的试验中比较参与者多样性.
主要成果:
- 当地实验室与白人参与者的百分比降低相关.
- 虚拟访问/电视访问与黑人参与者的比例降低相关.
- 设备/可穿戴设备没有显著的人口影响;家庭访问无法进行测试.
结论:
- 某些DCT解决方案,如本地实验室和虚拟访问,与临床试验群体的多样性改善有关.
- 需要进一步的研究来探索DCT对公平参与者代表性的全部影响.
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