快速开发一个注册表,以加速COVID-19疫苗临床试验
Neil F Abernethy1, Kylie McCloskey2, Meg Trahey2
1Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.
NPJ digital medicine
|May 6, 2025
概括
COVID-19预防网络 (CoVPN) 志愿者查登记 (VSR) 迅速招募了超过65万名参与者参加疫苗试验. 这个数字系统成功地招募了多样化的志愿者,证明了其在疫情防控方面的价值.
科学领域:
- 临床试验 临床试验
- 公共卫生 公共卫生
- 数字健康数字健康
背景情况:
- 由于SARS-CoV-2的流行,需要快速开发疫苗和进行临床试验.
- 协调大型临床试验需要有效的参与者招聘和管理.
研究的目的:
- 描述COVID-19预防网络 (CoVPN) 志愿者查注册表 (VSR) 的开发和实施.
- 评估VSR在招募不同参与者参加第三阶段疫苗试验方面的作用.
- 确定在加快临床试验环境中整合数字工具的经验教训.
主要方法:
- 该VSR系统包括三个基于Web的接口:志愿者问卷,网站门户和行政门户.
- 数据被收集到一个安全的数据库中,促进了志愿者选,地点分配和入学监测.
- 该系统能够提供关于招生进展和志愿者人口统计数据的动态分析报告.
主要成果:
- 在VSR收集了超过65万名志愿者,显著帮助招募多个第三阶段临床试验.
- 在166729名被选中进行查的志愿者中,超过47%属于优先组,确保多样性.
- 该系统在加速临床试验环境中展示了快速和安全的集成.
结论:
- 在成功招募大量和多样化的参与者池进行COVID-19疫苗试验时,VSR发挥了重要作用.
- 像VSR这样的数字工具可以在流行病应对环境中有效和安全地部署.
- 从VSR实施中吸取的经验教训可以为临床研究的未来的流行病准备策略提供信息.
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