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

Authors :
Fernando C. Maluf
Andreia Cristina de Melo
Angélica Nogueira-Rodrigues
Rachel P. Riechelmann
Denis Leonardo Fontes Jardim
Eva Bustamante
Daniela Dornelles Rosa
Gilberto de Castro
Gustavo Werutsky
Carlos Barrios
Henry Gomes
Maurício Fraga
Denisse Bretel
Raul Sala
Clarissa Mathias
William N. William
Andrés F. Cardona
Camilla Akemi Felizardo Yamada
Oscar Arrieta
Aline Bobato Lara Gongora
Diogo Assed Bastos
Source :
JCO Global Oncology
Publication Year :
2021
Publisher :
American Society of Clinical Oncology (ASCO), 2021.

Abstract

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.

Details

ISSN :
26878941
Database :
OpenAIRE
Journal :
JCO Global Oncology
Accession number :
edsair.doi.dedup.....88e705ef8b156d807093d8517ff3b612
Full Text :
https://doi.org/10.1200/go.20.00663