Abernethy Neil F, McCloskey Kylie, Trahey Meg, Rinn Laurie, Broder Gail, Andrasik Michele, Laborde Rebecca, McGhan Daniel, Spendolini Scott, Marimuthu Senthil, Kanzmeier Adam, Hanes Jayson, Kublin James G
Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.
HIV Vaccine Trials Network (HVTN), COVID-19 Prevention Network (CoVPN), Fred Hutchinson Cancer Center, Seattle, WA, USA.
NPJ Digit Med. 2025 May 6;8(1):251. doi: 10.1038/s41746-025-01666-3.
Response to the SARS-Cov-2 pandemic required the unprecedented, rapid activation of the COVID-19 Prevention Network (CoVPN) representing hundreds of sites conducting vaccine clinical trials. The CoVPN Volunteer Screening Registry (VSR) collected participant information, distributed qualified candidates across sites, and monitored enrollment progress. The system consisted of three web-based interfaces. The Volunteer Questionnaire flowed into a secure database. The Site Portal supported volunteer selection, analytics, and enrollment. The Administrative Portal enabled dynamic analytic reports by geography, clinical trial, and site, including volunteering rates over time. The VSR collected over 650,000 volunteers, serving a key role in the recruitment of diverse participants for multiple Phase 3 clinical trials. Over 47% of the 166,729 volunteers selected for screening represented prioritized groups. The success of the VSR demonstrates how digital tools can be rapidly yet safely integrated into an accelerated clinical trial setting. We summarize the development of the system and lessons learned for pandemic preparedness.
应对SARS-CoV-2大流行需要前所未有的迅速启动代表数百个进行疫苗临床试验地点的COVID-19预防网络（CoVPN）。CoVPN志愿者筛选登记处（VSR）收集参与者信息，在各地点分配合格候选人，并监测入组进度。该系统由三个基于网络的界面组成。志愿者问卷流入一个安全数据库。站点门户支持志愿者选择、分析和入组。管理门户可生成按地理区域、临床试验和站点划分的动态分析报告，包括随时间变化的志愿服务率。VSR收集了超过650,000名志愿者，在为多项3期临床试验招募不同参与者方面发挥了关键作用。在被选中进行筛选的166,729名志愿者中，超过47%代表优先群体。VSR的成功展示了数字工具如何能够快速且安全地融入加速的临床试验环境。我们总结了该系统的开发情况以及为大流行防范吸取的经验教训。
