دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: A framework and road map for rapid start-up and completion of a COVID-19 vaccine trial: A single clinical trial site experience
المؤلفون: Carlos Rojas, Stephen A. Spector, Bernadette Cale, Megan Loughran, Leander Lazaro, Eric Mah, Gary S. Firestein, Kathryn A. Gold, Mark Wallace
المصدر: Journal of Clinical and Translational Science, Vol 6 (2022)
بيانات النشر: Cambridge University Press, 2022.
سنة النشر: 2022
المجموعة: LCC:Medicine
مصطلحات موضوعية: COVID-19 vaccine, study start up, clinical trial project management, rapid enrollment, scalable systems, Medicine
الوصف: 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.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 2059-8661
Relation: https://www.cambridge.org/core/product/identifier/S2059866122000036/type/journal_article; https://doaj.org/toc/2059-8661
DOI: 10.1017/cts.2022.3
URL الوصول: https://doaj.org/article/670ad474749a41efa83c498aabd6995c
رقم الأكسشن: edsdoj.670ad474749a41efa83c498aabd6995c
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:20598661
DOI:10.1017/cts.2022.3