Cargando…

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-...

Descripción completa

Detalles Bibliográficos
Autores principales: Arai, Roberto J., Moniz, Camila M.V., Chen, André T.C., Mak, Milena P., Chammas, Roger, Hoff, Paulo M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
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
_version_ 1783570316902006784
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
work_keys_str_mv AT arairobertoj managingoncologyclinicaltrialsduringcovid19pandemic
AT monizcamilamv managingoncologyclinicaltrialsduringcovid19pandemic
AT chenandretc managingoncologyclinicaltrialsduringcovid19pandemic
AT makmilenap managingoncologyclinicaltrialsduringcovid19pandemic
AT chammasroger managingoncologyclinicaltrialsduringcovid19pandemic
AT hoffpaulom managingoncologyclinicaltrialsduringcovid19pandemic