Rapid development of a registry to accelerate COVID-19 vaccine clinical trials

Abstract

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.

Fig. 1. CoVPN VSR Overview flow chart.

This graphic shows how prospective volunteers submit information through the intake survey and are subsequently viewable through the Administrative Portal and the Site Portal for recruitment and enrollment into clinical trials.

Fig. 2. Administrative portal.

A variety of live reports from the database supported periodic monitoring of volunteering, site utilization, and enrollment according to time, geography, or clinical trial.

Fig. 3. Volunteer registrations over time and geography.

a Over 300,000 volunteers registered in the system within the first month. b The map shows the volunteering rate per 1000 adults in each state (mean = 2 × 23/1000 US adults).

Fig. 4. Enrollment of registry volunteers, by clinical trial and volunteer race/ethnicity.

The VSR enabled a high proportion of study participant enrollment from BIPOC communities, with approximately 80% and 60% from the VSR into Moderna and AstraZeneca, respectively.

Fig. 5. Site portal.

a Landing page showing six core functions; b Query volunteers function showing interactive filtering, descriptive statistics of volunteer demographics, and risk scores. c Interactive map of a site catchment area and volunteer density that enabled selection of volunteers from target regions.