Managing oncology clinical trials during COVID - 19 pandemic

São Paulo city is the epi cen ter of the Brazil ian COVID - 19 pan demic. The In sti tuto do Can cer do Es tado de São Paulo is cur rently con duct ing 161 multi na tional spon sored tri als plus 116 in house stud ies in the on co logic pop u la tion. There are 242 cur rently ac tive par tic i pants...

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Autores:
Tipo de recurso:
Article of investigation
Fecha de publicación:
2020
Institución:
Universidad de Bogotá Jorge Tadeo Lozano
Repositorio:
Expeditio: repositorio UTadeo
Idioma:
eng
OAI Identifier:
oai:expeditiorepositorio.utadeo.edu.co:20.500.12010/13819
Acceso en línea:
https://doi.org/10.1016/j.conctc.2020.100637
http://hdl.handle.net/20.500.12010/13819
Palabra clave:
Oncology clinical trials
COVID - 19
Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
Rights
License
Abierto (Texto Completo)
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dc.title.spa.fl_str_mv Managing oncology clinical trials during COVID - 19 pandemic
title Managing oncology clinical trials during COVID - 19 pandemic
spellingShingle Managing oncology clinical trials during COVID - 19 pandemic
Oncology clinical trials
COVID - 19
Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
title_short 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_sort Managing oncology clinical trials during COVID - 19 pandemic
dc.subject.spa.fl_str_mv Oncology clinical trials
COVID - 19
topic Oncology clinical trials
COVID - 19
Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
dc.subject.lemb.spa.fl_str_mv Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
description São Paulo city is the epi cen ter of the Brazil ian COVID - 19 pan demic. The In sti tuto do Can cer do Es tado de São Paulo is cur rently con duct ing 161 multi na tional spon sored tri als plus 116 in house stud ies in the on co logic pop u la tion. There are 242 cur rently ac tive par tic i pants and 180 pa tients in fol low - up. The man age ment of the tightly con trolled en vi ron ment of clin i cal re search be comes a chal lenge, and the Food and Drug Ad min is tra - tion set of pri or ity rec om men da tions for pa tient safety while main tain ing study in tegrity. Fast adap ta tions are nec es sary, and ac tions co a lesce to par tic i pant pro tec tion from COVID - 19. We pointed out crit i cal processes for ad just ments, and we be lieve that our ex pe ri ence may help other aca d e mic health cen ters.
publishDate 2020
dc.date.accessioned.none.fl_str_mv 2020-09-25T19:40:04Z
dc.date.available.none.fl_str_mv 2020-09-25T19:40:04Z
dc.date.created.none.fl_str_mv 2020
dc.type.local.spa.fl_str_mv Artículo
dc.type.coar.spa.fl_str_mv http://purl.org/coar/resource_type/c_2df8fbb1
format http://purl.org/coar/resource_type/c_2df8fbb1
dc.identifier.issn.spa.fl_str_mv 2451-8654
dc.identifier.other.spa.fl_str_mv https://doi.org/10.1016/j.conctc.2020.100637
dc.identifier.uri.none.fl_str_mv http://hdl.handle.net/20.500.12010/13819
dc.identifier.doi.spa.fl_str_mv https://doi.org/10.1016/j.conctc.2020.100637
identifier_str_mv 2451-8654
url https://doi.org/10.1016/j.conctc.2020.100637
http://hdl.handle.net/20.500.12010/13819
dc.language.iso.spa.fl_str_mv eng
language eng
dc.rights.coar.fl_str_mv http://purl.org/coar/access_right/c_abf2
dc.rights.local.spa.fl_str_mv Abierto (Texto Completo)
rights_invalid_str_mv Abierto (Texto Completo)
http://purl.org/coar/access_right/c_abf2
dc.format.extent.spa.fl_str_mv 3 páginas
dc.format.mimetype.spa.fl_str_mv application/pdf
dc.publisher.spa.fl_str_mv Contemporary Clinical Trials Communications
dc.source.spa.fl_str_mv reponame:Expeditio Repositorio Institucional UJTL
instname:Universidad de Bogotá Jorge Tadeo Lozano
instname_str Universidad de Bogotá Jorge Tadeo Lozano
institution Universidad de Bogotá Jorge Tadeo Lozano
reponame_str Expeditio Repositorio Institucional UJTL
collection Expeditio Repositorio Institucional UJTL
bitstream.url.fl_str_mv https://expeditiorepositorio.utadeo.edu.co/bitstream/20.500.12010/13819/2/license.txt
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spelling 2020-09-25T19:40:04Z2020-09-25T19:40:04Z20202451-8654https://doi.org/10.1016/j.conctc.2020.100637http://hdl.handle.net/20.500.12010/13819https://doi.org/10.1016/j.conctc.2020.100637São Paulo city is the epi cen ter of the Brazil ian COVID - 19 pan demic. The In sti tuto do Can cer do Es tado de São Paulo is cur rently con duct ing 161 multi na tional spon sored tri als plus 116 in house stud ies in the on co logic pop u la tion. There are 242 cur rently ac tive par tic i pants and 180 pa tients in fol low - up. The man age ment of the tightly con trolled en vi ron ment of clin i cal re search be comes a chal lenge, and the Food and Drug Ad min is tra - tion set of pri or ity rec om men da tions for pa tient safety while main tain ing study in tegrity. Fast adap ta tions are nec es sary, and ac tions co a lesce to par tic i pant pro tec tion from COVID - 19. We pointed out crit i cal processes for ad just ments, and we be lieve that our ex pe ri ence may help other aca d e mic health cen ters.3 páginasapplication/pdfengContemporary Clinical Trials Communicationsreponame:Expeditio Repositorio Institucional UJTLinstname:Universidad de Bogotá Jorge Tadeo LozanoOncology clinical trialsCOVID - 19Síndrome respiratorio agudo graveCOVID-19SARS-CoV-2CoronavirusManaging oncology clinical trials during COVID - 19 pandemicArtículohttp://purl.org/coar/resource_type/c_2df8fbb1Abierto (Texto Completo)http://purl.org/coar/access_right/c_abf2Arai, Roberto J.Moniz, Camila M. V.Chen, André T. C.Mak, Milena P.Chammas, RogerHof, Paulo M.LICENSElicense.txtlicense.txttext/plain; charset=utf-82938https://expeditiorepositorio.utadeo.edu.co/bitstream/20.500.12010/13819/2/license.txtabceeb1c943c50d3343516f9dbfc110fMD52open accessTHUMBNAILManaging-oncology-clinical-trials-during-_2020_Contemporary-Clinical-Trials-.pdf.jpgManaging-oncology-clinical-trials-during-_2020_Contemporary-Clinical-Trials-.pdf.jpgIM Thumbnailimage/jpeg16403https://expeditiorepositorio.utadeo.edu.co/bitstream/20.500.12010/13819/3/Managing-oncology-clinical-trials-during-_2020_Contemporary-Clinical-Trials-.pdf.jpg6fc9384e01801814ca22bfb0333b02a9MD53open access20.500.12010/13819oai:expeditiorepositorio.utadeo.edu.co:20.500.12010/138192021-03-17 20:33:13.002metadata only accessRepositorio Institucional - Universidad Jorge Tadeo Lozanoexpeditio@utadeo.edu.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