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

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...

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Autores principales: Lara Gongora, Aline B., Werutsky, Gustavo, Jardim, Denis L., Nogueira-Rodrigues, Angelica, Barrios, Carlos H., Mathias, Clarissa, Maluf, Fernando, Riechelmann, Rachel, Fraga, Maurício, Gomes, Henry, William, William N., Yamada, Camilla A. F., de Castro Jr, Gilberto, Rosa, Daniela D., de Melo, Andreia C., Sala, Raul, Bustamante, Eva, Bretel, Denisse, Arrieta, Oscar, Cardona, Andrés F., Bastos, Diogo A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162498/
https://www.ncbi.nlm.nih.gov/pubmed/33956499
http://dx.doi.org/10.1200/GO.20.00663
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author Lara Gongora, Aline B.
Werutsky, Gustavo
Jardim, Denis L.
Nogueira-Rodrigues, Angelica
Barrios, Carlos H.
Mathias, Clarissa
Maluf, Fernando
Riechelmann, Rachel
Fraga, Maurício
Gomes, Henry
William, William N.
Yamada, Camilla A. F.
de Castro Jr, Gilberto
Rosa, Daniela D.
de Melo, Andreia C.
Sala, Raul
Bustamante, Eva
Bretel, Denisse
Arrieta, Oscar
Cardona, Andrés F.
Bastos, Diogo A.
author_facet Lara Gongora, Aline B.
Werutsky, Gustavo
Jardim, Denis L.
Nogueira-Rodrigues, Angelica
Barrios, Carlos H.
Mathias, Clarissa
Maluf, Fernando
Riechelmann, Rachel
Fraga, Maurício
Gomes, Henry
William, William N.
Yamada, Camilla A. F.
de Castro Jr, Gilberto
Rosa, Daniela D.
de Melo, Andreia C.
Sala, Raul
Bustamante, Eva
Bretel, Denisse
Arrieta, Oscar
Cardona, Andrés F.
Bastos, Diogo A.
author_sort Lara Gongora, Aline B.
collection PubMed
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.
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spelling pubmed-81624982021-06-01 Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420) Lara Gongora, Aline B. Werutsky, Gustavo Jardim, Denis L. Nogueira-Rodrigues, Angelica Barrios, Carlos H. Mathias, Clarissa Maluf, Fernando Riechelmann, Rachel Fraga, Maurício Gomes, Henry William, William N. Yamada, Camilla A. F. de Castro Jr, Gilberto Rosa, Daniela D. de Melo, Andreia C. Sala, Raul Bustamante, Eva Bretel, Denisse Arrieta, Oscar Cardona, Andrés F. Bastos, Diogo A. JCO Glob Oncol ORIGINAL REPORTS 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. Wolters Kluwer Health 2021-05-06 /pmc/articles/PMC8162498/ /pubmed/33956499 http://dx.doi.org/10.1200/GO.20.00663 Text en © 2021 by American Society of Clinical Oncology https://creativecommons.org/licenses/by/4.0/Licensed under the Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/
spellingShingle ORIGINAL REPORTS
Lara Gongora, Aline B.
Werutsky, Gustavo
Jardim, Denis L.
Nogueira-Rodrigues, Angelica
Barrios, Carlos H.
Mathias, Clarissa
Maluf, Fernando
Riechelmann, Rachel
Fraga, Maurício
Gomes, Henry
William, William N.
Yamada, Camilla A. F.
de Castro Jr, Gilberto
Rosa, Daniela D.
de Melo, Andreia C.
Sala, Raul
Bustamante, Eva
Bretel, Denisse
Arrieta, Oscar
Cardona, Andrés F.
Bastos, Diogo A.
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)
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_short 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)
topic ORIGINAL REPORTS
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162498/
https://www.ncbi.nlm.nih.gov/pubmed/33956499
http://dx.doi.org/10.1200/GO.20.00663
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