Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)

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Purpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments.Methods: This was a c...

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Autores: Lara Gongora, AB, Werutsky, G, Jardim, DL, Nogueira-Rodrigues, A, Barrios, CH, Mathias, C, Maluf, F, Riechelmann, R, Fraga, M, Gomes, H, William, WN, Yamada, CAF, de Castro, G Jr, Rosa, DD, de Melo, AC, Sala, R, Bustamante, E, Bretel, D, Arrieta, O, Cardona, AF, Bastos, DA
Formato: artículo
Fecha de Publicación:2021
Institución:Instituto Nacional de Enfermedades Neoplásicas
Repositorio:INEN-Institucional
Lenguaje:inglés
OAI Identifier:oai:repositorio.inen.sld.pe:20.500.14703/84
Enlace del recurso:https://hdl.handle.net/20.500.14703/84
Nivel de acceso:acceso abierto
Materia:COVID-19 Pandemic
Latin America
https://purl.org/pe-repo/ocde/ford#3.02.21
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spelling PublicationLara Gongora, ABWerutsky, GJardim, DLNogueira-Rodrigues, ABarrios, CHMathias, CMaluf, FRiechelmann, RFraga, MGomes, HWilliam, WNYamada, CAFde Castro, G JrRosa, DDde Melo, ACSala, RBustamante, EBretel, DArrieta, OCardona, AFBastos, DA2024-06-12T17:34:00Z2024-06-12T17:34:00Z202110.1200/GO.20.00663https://hdl.handle.net/20.500.14703/84JCO Glob OncolPurpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments.Methods: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group.Results: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. Conclusion: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.application/pdfengAmerican Society of Clinical OncologyUSinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/4.0/COVID-19 PandemicLatin Americahttps://purl.org/pe-repo/ocde/ford#3.02.21Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionreponame:INEN-Institucionalinstname:Instituto Nacional de Enfermedades Neoplásicasinstacron:INENORIGINALLara Gongora 2021.pdfapplication/pdf532570https://repositorio.inen.sld.pe/backend/api/core/bitstreams/2b80d86d-6b65-4afd-ba2e-30914848856e/download65859e7fa8b3739047ccdc5b8eaa5a76MD51trueAnonymousREADTEXTLara Gongora 2021.pdf.txtWritten by FormatFilter org.dspace.app.mediafilter.TikaTextExtractionFilter on 2025-03-29T20:41:10Z (GMT).Extracted texttext/plain48563https://repositorio.inen.sld.pe/backend/api/core/bitstreams/9f5e198d-01a9-45e4-abdc-f9814ba37318/download0257e65f760742998f3ef1b90493ca40MD54falseAnonymousREADTHUMBNAILLara Gongora 2021.pdf.jpgWritten by FormatFilter org.dspace.app.mediafilter.PDFBoxThumbnail on 2025-03-29T20:41:10Z (GMT).Generated Thumbnailimage/jpeg49639https://repositorio.inen.sld.pe/backend/api/core/bitstreams/98ecf3c8-912c-454e-b71a-1843ac32f3b6/downloadcc25f573212b06a765b7eac0fb88dc7eMD55falseAnonymousREAD20.500.14703/84oai:repositorio.inen.sld.pe:20.500.14703/842026-02-17T15:57:27.867Zhttps://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessopen.accesshttps://repositorio.inen.sld.peRepositorio del Instituto Nacional de Enfermedades Neoplásicasrepositorio@inen.sld.pe
dc.title.none.fl_str_mv Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
title Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
spellingShingle Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
Lara Gongora, AB
COVID-19 Pandemic
Latin America
https://purl.org/pe-repo/ocde/ford#3.02.21
title_short Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
title_full Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
title_fullStr Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
title_full_unstemmed Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
title_sort Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
author Lara Gongora, AB
author_facet Lara Gongora, AB
Werutsky, G
Jardim, DL
Nogueira-Rodrigues, A
Barrios, CH
Mathias, C
Maluf, F
Riechelmann, R
Fraga, M
Gomes, H
William, WN
Yamada, CAF
de Castro, G Jr
Rosa, DD
de Melo, AC
Sala, R
Bustamante, E
Bretel, D
Arrieta, O
Cardona, AF
Bastos, DA
author_role author
author2 Werutsky, G
Jardim, DL
Nogueira-Rodrigues, A
Barrios, CH
Mathias, C
Maluf, F
Riechelmann, R
Fraga, M
Gomes, H
William, WN
Yamada, CAF
de Castro, G Jr
Rosa, DD
de Melo, AC
Sala, R
Bustamante, E
Bretel, D
Arrieta, O
Cardona, AF
Bastos, DA
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Lara Gongora, AB
Werutsky, G
Jardim, DL
Nogueira-Rodrigues, A
Barrios, CH
Mathias, C
Maluf, F
Riechelmann, R
Fraga, M
Gomes, H
William, WN
Yamada, CAF
de Castro, G Jr
Rosa, DD
de Melo, AC
Sala, R
Bustamante, E
Bretel, D
Arrieta, O
Cardona, AF
Bastos, DA
dc.subject.none.fl_str_mv COVID-19 Pandemic
Latin America
topic COVID-19 Pandemic
Latin America
https://purl.org/pe-repo/ocde/ford#3.02.21
dc.subject.ocde.none.fl_str_mv https://purl.org/pe-repo/ocde/ford#3.02.21
description Purpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments.Methods: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group.Results: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. Conclusion: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.
publishDate 2021
dc.date.accessioned.none.fl_str_mv 2024-06-12T17:34:00Z
dc.date.available.none.fl_str_mv 2024-06-12T17:34:00Z
dc.date.issued.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
dc.type.version.none.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.doi.none.fl_str_mv 10.1200/GO.20.00663
dc.identifier.uri.none.fl_str_mv https://hdl.handle.net/20.500.14703/84
dc.identifier.journal.none.fl_str_mv JCO Glob Oncol
identifier_str_mv 10.1200/GO.20.00663
JCO Glob Oncol
url https://hdl.handle.net/20.500.14703/84
dc.language.iso.none.fl_str_mv eng
language eng
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
dc.rights.uri.none.fl_str_mv https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
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dc.publisher.none.fl_str_mv American Society of Clinical Oncology
dc.publisher.country.none.fl_str_mv US
publisher.none.fl_str_mv American Society of Clinical Oncology
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