快速开发注册表以加快COVID-19疫苗临床试验的速度
Neil F Abernethy1, Kylie McCloskey2, Meg Trahey2
1Biomedical Informatics and Medical Education, University of Washington, 850 Republican St., Seattle, WA 98109.
Research square
|July 1, 2024
概括
COVID-19预防网络 (CoVPN) 志愿者查登记 (VSR) 迅速招募了超过65万名志愿者参加关键疫苗试验. 这种安全系统在疫情期间增强了临床试验的多样性和进展.
科学领域:
- 临床信息学 临床信息学
- 公共卫生准备情况 公共卫生准备情况
- 疫苗开发 疫苗开发
背景情况:
- 由于SARS-CoV-2大流行,疫苗和治疗药物的临床试验需要迅速启动.
- COVID-19预防网络 (CoVPN) 协调了许多场所进行第二期和第三期试验.
- CoVPN志愿者查注册表 (VSR) 成立,以管理大规模的志愿者数据.
研究的目的:
- 描述CoVPN志愿者查注册表 (VSR) 的开发和实施.
- 概述该系统在促进大规模的临床试验中的作用.
- 突出VSR对志愿者招募和试验多样性的贡献.
主要方法:
- 开发了一个安全的数据库,为志愿者,临床站点和管理人员提供基于Web的接口.
- 实施了志愿者招募,风险评估,候选人分配和进度监测的功能.
- 利用过器,视觉分析和报告工具,以有效管理试验.
主要成果:
- 超过65万名志愿者在VSR注册,其中1094名用户接受了培训.
- 在主要的COVID-19疫苗试验中,VSR对于招募参与者至关重要,增强了多样性.
- 临床站点选了166,729条记录,其中47.7%来自优先组;系统正常运行时间为99.99%.
结论:
- 信息工具可以通过公私伙伴关系快速开展临床试验,从而快速安全地开发信息工具.
- 该VSR模型证明了成功地集成到分布式临床试验环境中.
- 从VSR开发中吸取的经验教训对于未来的流行病准备有价值.
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