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Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach
Background: COVID-19 is an unprecedented global health emergency. It has been highly disruptive for patients with cancer, both due to an increased burden of severe illness and due to pressure on healthcare systems. COVID-19 vaccination has been an important public health measure for this patient gro...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9785949/ https://www.ncbi.nlm.nih.gov/pubmed/36560412 http://dx.doi.org/10.3390/vaccines10122003 |
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author | Body, Amy Milch, Vivienne McSorley, Lynda Lal, Luxi Ahern, Elizabeth Ryan, Regina Jones, Gayle Keefe, Dorothy Segelov, Eva |
author_facet | Body, Amy Milch, Vivienne McSorley, Lynda Lal, Luxi Ahern, Elizabeth Ryan, Regina Jones, Gayle Keefe, Dorothy Segelov, Eva |
author_sort | Body, Amy |
collection | PubMed |
description | Background: COVID-19 is an unprecedented global health emergency. It has been highly disruptive for patients with cancer, both due to an increased burden of severe illness and due to pressure on healthcare systems. COVID-19 vaccination has been an important public health measure for this patient group. Aim: The aim of this study was to describe the rapid design and startup of a multicentre study of COVID-19 vaccine response for vulnerable patients with cancer. Study startup: We set up a multicentre prospective observational study of COVID-19 vaccination response for Australian patients with cancer. Due to intensive collaboration between health services, the funding body and laboratories, we were able to develop a protocol and enrol the first patient within 52 days of the initial study proposal. Rapid startup was further enabled by prompt availability of funding and by high-level engagement of institutional review boards, allowing expedited review. Study enrolment: We rapidly enroled more than 500 patients, 80% within 4 months of study opening. Engagement and follow-up were maintained throughout the course of up to five serial vaccination doses. Conclusion: Our study is an example of intensive collaboration inspired by the COVID-19 pandemic and may serve as an example of an agile research response to real-time public health challenges. |
format | Online Article Text |
id | pubmed-9785949 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-97859492022-12-24 Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach Body, Amy Milch, Vivienne McSorley, Lynda Lal, Luxi Ahern, Elizabeth Ryan, Regina Jones, Gayle Keefe, Dorothy Segelov, Eva Vaccines (Basel) Article Background: COVID-19 is an unprecedented global health emergency. It has been highly disruptive for patients with cancer, both due to an increased burden of severe illness and due to pressure on healthcare systems. COVID-19 vaccination has been an important public health measure for this patient group. Aim: The aim of this study was to describe the rapid design and startup of a multicentre study of COVID-19 vaccine response for vulnerable patients with cancer. Study startup: We set up a multicentre prospective observational study of COVID-19 vaccination response for Australian patients with cancer. Due to intensive collaboration between health services, the funding body and laboratories, we were able to develop a protocol and enrol the first patient within 52 days of the initial study proposal. Rapid startup was further enabled by prompt availability of funding and by high-level engagement of institutional review boards, allowing expedited review. Study enrolment: We rapidly enroled more than 500 patients, 80% within 4 months of study opening. Engagement and follow-up were maintained throughout the course of up to five serial vaccination doses. Conclusion: Our study is an example of intensive collaboration inspired by the COVID-19 pandemic and may serve as an example of an agile research response to real-time public health challenges. MDPI 2022-11-24 /pmc/articles/PMC9785949/ /pubmed/36560412 http://dx.doi.org/10.3390/vaccines10122003 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Body, Amy Milch, Vivienne McSorley, Lynda Lal, Luxi Ahern, Elizabeth Ryan, Regina Jones, Gayle Keefe, Dorothy Segelov, Eva Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach |
title | Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach |
title_full | Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach |
title_fullStr | Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach |
title_full_unstemmed | Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach |
title_short | Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach |
title_sort | rapid protocol development, study startup and enrolment of a prospective study of covid-19 vaccination for patients with cancer: a collaborative approach |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9785949/ https://www.ncbi.nlm.nih.gov/pubmed/36560412 http://dx.doi.org/10.3390/vaccines10122003 |
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