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Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine

The sudden emergence of the coronavirus disease 2019 (COVID-19) pandemic in early 2020 stimulated unprecedented scientific initiatives to rapidly develop effective treatments and vaccines. One example was the development of vaccines based on messenger RNA platforms, which received emergency use auth...

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Autor principal: Hyer, Randall N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8974181/
https://www.ncbi.nlm.nih.gov/pubmed/35333501
http://dx.doi.org/10.1097/PPO.0000000000000587
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author Hyer, Randall N.
author_facet Hyer, Randall N.
author_sort Hyer, Randall N.
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description The sudden emergence of the coronavirus disease 2019 (COVID-19) pandemic in early 2020 stimulated unprecedented scientific initiatives to rapidly develop effective treatments and vaccines. One example was the development of vaccines based on messenger RNA platforms, which received emergency use authorization in the United States less than 1 year after the primary sequence of the severe acute respiratory syndrome coronavirus 2 virus was published. Novel practices arose from the collaborative efforts and inclusive clinical studies that facilitated the vaccines' rapid development and clinical testing. I describe insights gained from the experience of mRNA-1273 vaccine development that may be applied to or adapted for oncology research. These insights include clinical study design, diversity and inclusion initiatives, speed, and real-world evidence generation, as well as close partnership among regulatory agencies, government, and pharmaceutical companies.
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spelling pubmed-89741812022-04-01 Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine Hyer, Randall N. Cancer J Review Articles The sudden emergence of the coronavirus disease 2019 (COVID-19) pandemic in early 2020 stimulated unprecedented scientific initiatives to rapidly develop effective treatments and vaccines. One example was the development of vaccines based on messenger RNA platforms, which received emergency use authorization in the United States less than 1 year after the primary sequence of the severe acute respiratory syndrome coronavirus 2 virus was published. Novel practices arose from the collaborative efforts and inclusive clinical studies that facilitated the vaccines' rapid development and clinical testing. I describe insights gained from the experience of mRNA-1273 vaccine development that may be applied to or adapted for oncology research. These insights include clinical study design, diversity and inclusion initiatives, speed, and real-world evidence generation, as well as close partnership among regulatory agencies, government, and pharmaceutical companies. Lippincott Williams & Wilkins 2022 2022-03-28 /pmc/articles/PMC8974181/ /pubmed/35333501 http://dx.doi.org/10.1097/PPO.0000000000000587 Text en Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.
spellingShingle Review Articles
Hyer, Randall N.
Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine
title Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine
title_full Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine
title_fullStr Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine
title_full_unstemmed Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine
title_short Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine
title_sort insights for oncology trials garnered from the rapid development of an mrna covid-19 vaccine
topic Review Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8974181/
https://www.ncbi.nlm.nih.gov/pubmed/35333501
http://dx.doi.org/10.1097/PPO.0000000000000587
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