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[Preprint]. 2024 Jun 10:rs.3.rs-4397271.
doi: 10.21203/rs.3.rs-4397271/v1.

Rapid Development of a Registry to Accelerate COVID-19 Vaccine Clinical Trials

Neil F Abernethy  1 , Kylie McCloskey  2 , Meg Trahey  2 , Laurie Rinn  3 , Gail B Broder  2 , Michele Andrasik  2 , Rebecca Laborde  4 , Daniel McGhan  4 , Scott Spendolini  4 , Senthil Marimuthu  4 , Adam Kanzmeier  4 , Jayson Hanes  4 , James Kublin  2
Affiliations

Rapid Development of a Registry to Accelerate COVID-19 Vaccine Clinical Trials

Neil F Abernethy et al. Res Sq. .

Update in

Abstract

Background: The unprecedented scientific response to the SARS-Cov-2 pandemic in 2020 required the rapid development and activation of extensive clinical trial networks to study vaccines and therapeutics. The COVID-19 Prevention Network (CoVPN) coordinated hundreds of sites conducting phase 2 and 3 clinical trials of vaccines and antibody therapeutics. To facilitate these clinical trials, the CoVPN Volunteer Screening Registry (VSR) was created to collect volunteer information at scale, identify volunteers at risk of COVID-19 who met enrollment criteria, distribute candidates across clinical trial sites, and enable monitoring of volunteering and enrollment progress.

Methods: We developed a secure database to support three primary web-based interfaces: a national volunteer questionnaire intake form, a clinical trial site portal, and an Administrative Portal. The Site Portal supported filters based on volunteer attributes, visual analytics, enrollment status tracking, geographic search, and clinical risk prediction. The Administrative Portal supported oversight and development with pre-specified reports aggregated by geography, trial, and trial site; charts of volunteer rates over time; volunteer risk score calculation; and dynamic, user-defined reports.

Findings: Over 650,000 volunteers joined the VSR, and 1094 users were trained to utilize the system. The VSR played a key role in recruitment for the Moderna, Oxford-AstraZeneca, Janssen, and Novavax vaccine clinical trials, provided support to the Pfizer and Sanofi vaccine and prophylactic antibody clinical trials, and enhanced the diversity of trial participants. Clinical trial sites selected 166,729 volunteer records for follow-up screening, and of these 47·7% represented groups prioritized for increased enrollment. Despite the unprecedented urgency of its development, the system maintained 99·99% uptime.

Interpretation: The success of the VSR demonstrates that information tools can be rapidly yet safely developed through a public-private partnership and integrated into a distributed and accelerated clinical trial setting. We further summarize the requirements, design, and development of the system, and discuss lessons learned for future pandemic preparedness.

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Conflict of interest statement

Declaration of interests JK, NFA, KM, GBB, MT, and LR declare no conflicts; RL, SS, AK, DM, SM, and JH are employed by Oracle Corporation and hold stock options.

Figures

Figure 1.
Figure 1.. 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.
Figure 1.
Figure 1.. 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.
Figure 2.
Figure 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.
Figure 3.
Figure 3.. Volunteer registrations over time and geography.
Over 300,000 volunteers registered in the system within the first month. The map shows the volunteering rate per 1000 adults in each state (mean = 2·23 / 1000 US adults).
See this image and copyright information in PMC

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