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Rapid Development of a Registry to Accelerate COVID-19 Vaccine Clinical Trials
Neil F Abernethy1, Kylie McCloskey2, Meg Trahey2
1Biomedical Informatics and Medical Education, University of Washington, 850 Republican St., Seattle, WA 98109.
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.
Insights
The COVID-19 Prevention Network (CoVPN) Volunteer Screening Registry (VSR) rapidly enrolled over 650,000 volunteers for critical vaccine trials. This secure system enhanced clinical trial diversity and progress during the pandemic.
Area of Science:
- Clinical Informatics
- Public Health Preparedness
- Vaccine Development
Background:
- The SARS-CoV-2 pandemic necessitated rapid clinical trial activation for vaccines and therapeutics.
- The COVID-19 Prevention Network (CoVPN) coordinated numerous sites for phase 2 and 3 trials.
- The CoVPN Volunteer Screening Registry (VSR) was established to manage volunteer data at scale.
Purpose of the Study:
- To describe the development and implementation of the CoVPN Volunteer Screening Registry (VSR).
- To outline the system's role in facilitating large-scale clinical trials during a pandemic.
- To highlight the VSR's contribution to volunteer recruitment and trial diversity.
Main Methods:
- Developed a secure database with web-based interfaces for volunteers, clinical sites, and administration.
- Implemented features for volunteer intake, risk assessment, candidate distribution, and progress monitoring.
- Utilized filters, visual analytics, and reporting tools for efficient trial management.
Main Results:
- Over 650,000 volunteers registered in the VSR, with 1094 users trained.
- The VSR was crucial for recruiting participants in major COVID-19 vaccine trials, enhancing diversity.
- Clinical sites screened 166,729 records, with 47.7% from prioritized groups; system uptime was 99.99%.
Conclusions:
- Information tools can be rapidly and safely developed via public-private partnerships for accelerated clinical trials.
- The VSR model demonstrates successful integration into distributed clinical trial settings.
- Lessons learned from the VSR development are valuable for future pandemic preparedness.
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