A framework and road map for rapid start-up and completion of a COVID-19 vaccine trial: A single clinical trial site experience

The COVID-19 global pandemic required the rapid development of vaccines with a quick start up of phase 1–3 studies with large enrollment targets. The University of California San Diego was identified as a site for the phase 3 trial of the mRNA-1273-SARS-CoV-2 vaccine. There were many challenges with...

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Published inJournal of clinical and translational science Vol. 6; no. 1; p. e21
Main Authors Rojas, Carlos, Spector, Stephen A., Cale, Bernadette, Loughran, Megan, Lazaro, Leander, Mah, Eric, Firestein, Gary S., Gold, Kathryn A., Wallace, Mark
Format Journal Article
LanguageEnglish
Published England Cambridge University Press 2022
Subjects
Audiences
clinical trial project management
Clinical trials
Communication
Community
Coronaviruses
COVID-19 vaccine
COVID-19 vaccines
Document management
Enrollments
mRNA
Pandemics
Pharmacists
Project management
rapid enrollment
Research Methods and Technology
scalable systems
Scheduling
Severe acute respiratory syndrome coronavirus 2
Startups
study start up
Teams
Translational Science Case Study
Vaccines
COVID-19 vaccine
rapid enrollment
clinical trial project management
scalable systems
study start up
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ISSN2059-8661
2059-8661
DOI10.1017/cts.2022.3

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Summary:The COVID-19 global pandemic required the rapid development of vaccines with a quick start up of phase 1–3 studies with large enrollment targets. The University of California San Diego was identified as a site for the phase 3 trial of the mRNA-1273-SARS-CoV-2 vaccine. There were many challenges with scaling up a large-scale clinical trial in such a short time. This report describes the processes and procedures that were implemented to successfully complete the enrollment target in under 10 weeks. This required the team to identify existing tools that could rapidly be accessed to develop a database, scheduling system, effective communication, document management, staff time tracking/efficiency, subject scheduling/tracking, project management, and accrual/study performance. The outcome of these efforts resulted in rapid enrollment and study completion in a short time. The lessons learned from this experience can be used by other clinical trial sites faced with similar challenges.
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ISSN:2059-8661
2059-8661
DOI:10.1017/cts.2022.3