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Managing oncology clinical trials during COVID-19 pandemic
São Paulo city is the epicenter of the Brazilian COVID-19 pandemic. The Instituto do Cancer do Estado de São Paulo is currently conducting 161 multinational sponsored trials plus 116 in house studies in the oncologic population. There are 242 currently active participants and 180 patients in follow-...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7424329/ https://www.ncbi.nlm.nih.gov/pubmed/32835128 http://dx.doi.org/10.1016/j.conctc.2020.100637 |
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author | Arai, Roberto J. Moniz, Camila M.V. Chen, André T.C. Mak, Milena P. Chammas, Roger Hoff, Paulo M. |
author_facet | Arai, Roberto J. Moniz, Camila M.V. Chen, André T.C. Mak, Milena P. Chammas, Roger Hoff, Paulo M. |
author_sort | Arai, Roberto J. |
collection | PubMed |
description | São Paulo city is the epicenter of the Brazilian COVID-19 pandemic. The Instituto do Cancer do Estado de São Paulo is currently conducting 161 multinational sponsored trials plus 116 in house studies in the oncologic population. There are 242 currently active participants and 180 patients in follow-up. The management of the tightly controlled environment of clinical research becomes a challenge, and the Food and Drug Administration set of priority recommendations for patient safety while maintaining study integrity. Fast adaptations are necessary, and actions coalesce to participant protection from COVID-19. We pointed out critical processes for adjustments, and we believe that our experience may help other academic health centers. |
format | Online Article Text |
id | pubmed-7424329 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-74243292020-08-13 Managing oncology clinical trials during COVID-19 pandemic Arai, Roberto J. Moniz, Camila M.V. Chen, André T.C. Mak, Milena P. Chammas, Roger Hoff, Paulo M. Contemp Clin Trials Commun Article São Paulo city is the epicenter of the Brazilian COVID-19 pandemic. The Instituto do Cancer do Estado de São Paulo is currently conducting 161 multinational sponsored trials plus 116 in house studies in the oncologic population. There are 242 currently active participants and 180 patients in follow-up. The management of the tightly controlled environment of clinical research becomes a challenge, and the Food and Drug Administration set of priority recommendations for patient safety while maintaining study integrity. Fast adaptations are necessary, and actions coalesce to participant protection from COVID-19. We pointed out critical processes for adjustments, and we believe that our experience may help other academic health centers. Elsevier 2020-08-13 /pmc/articles/PMC7424329/ /pubmed/32835128 http://dx.doi.org/10.1016/j.conctc.2020.100637 Text en © 2020 The Authors. Published by Elsevier Inc. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Arai, Roberto J. Moniz, Camila M.V. Chen, André T.C. Mak, Milena P. Chammas, Roger Hoff, Paulo M. Managing oncology clinical trials during COVID-19 pandemic |
title | Managing oncology clinical trials during COVID-19 pandemic |
title_full | Managing oncology clinical trials during COVID-19 pandemic |
title_fullStr | Managing oncology clinical trials during COVID-19 pandemic |
title_full_unstemmed | Managing oncology clinical trials during COVID-19 pandemic |
title_short | Managing oncology clinical trials during COVID-19 pandemic |
title_sort | managing oncology clinical trials during covid-19 pandemic |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7424329/ https://www.ncbi.nlm.nih.gov/pubmed/32835128 http://dx.doi.org/10.1016/j.conctc.2020.100637 |
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