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 in | Journal of clinical and translational science Vol. 6; no. 1; p. e21 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Cambridge University Press
2022
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| Subjects | |
| Online Access | Get full text |
| ISSN | 2059-8661 2059-8661 |
| DOI | 10.1017/cts.2022.3 |
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| Abstract | 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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| AbstractList | 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.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. 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. |
| ArticleNumber | e21 |
| Author | Spector, Stephen A. Rojas, Carlos Loughran, Megan Cale, Bernadette Mah, Eric Gold, Kathryn A. Wallace, Mark Firestein, Gary S. Lazaro, Leander |
| AuthorAffiliation | 6 Division of Pain Medicine, Department of Anesthesiology, Altman Clinical & Translational Research Institute, University of California San Diego , San Diego , California , USA 2 Division of Infectious Diseases, Mother-Child-Adolescent HIV Program, University of California San Diego and Rady Children’s Hospital , San Diego , California , USA 3 Mother-Child-Adolescent HIV Program, University of California San Diego , San Diego , California , USA 5 Division of Hematology and Oncology, Altman Clinical & Translational Research Institute, University of California San Diego , San Diego , California , USA 1 Altman Clinical & Translational Research Institute, University of California San Diego , San Diego , California , USA 4 Department of Medicine, Altman Clinical & Translational Research Institute, University of California San Diego , San Diego , California , USA |
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| Cites_doi | 10.1007/978-1-4842-0805-2 10.1056/NEJMoa2035389 10.1109/IT48810.2020.9070420 10.1056/NEJMoa2022483 10.1007/978-1-4842-6898-8 10.1016/j.jbi.2008.08.010 |
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| SubjectTerms | 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 |
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| Title | A framework and road map for rapid start-up and completion of a COVID-19 vaccine trial: A single clinical trial site experience |
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