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Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic

PURPOSE: Clinical trial enrollment has declined globally as a result of the coronavirus disease 2019 (COVID-19) pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently. METHODS AND MATERIALS: We report the effect of a phased trial...

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Autores principales: Yeboa, Debra Nana, Akinfenwa, Chidinma Anakwenze, Nguyen, Jonathan, Amaya, Diana, de Gracia, Beth, Ning, Matthew, Cox, Victoria, De, Brian, Smith, Benjamin D., Lin, Lili, Beddar, Sam, Hoang, Hanh, Koong, Albert, Liao, Zhongxing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927592/
https://www.ncbi.nlm.nih.gov/pubmed/33686374
http://dx.doi.org/10.1016/j.adro.2021.100676
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author Yeboa, Debra Nana
Akinfenwa, Chidinma Anakwenze
Nguyen, Jonathan
Amaya, Diana
de Gracia, Beth
Ning, Matthew
Cox, Victoria
De, Brian
Smith, Benjamin D.
Lin, Lili
Beddar, Sam
Hoang, Hanh
Koong, Albert
Liao, Zhongxing
author_facet Yeboa, Debra Nana
Akinfenwa, Chidinma Anakwenze
Nguyen, Jonathan
Amaya, Diana
de Gracia, Beth
Ning, Matthew
Cox, Victoria
De, Brian
Smith, Benjamin D.
Lin, Lili
Beddar, Sam
Hoang, Hanh
Koong, Albert
Liao, Zhongxing
author_sort Yeboa, Debra Nana
collection PubMed
description PURPOSE: Clinical trial enrollment has declined globally as a result of the coronavirus disease 2019 (COVID-19) pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently. METHODS AND MATERIALS: We report the effect of a phased trial reopening strategy, remote research staffing, and telemedicine on cancer trial enrollment at one of the largest radiation oncology academic cancer centers. In phase 1, trials investigating definitive therapeutic benefit were opened, followed by trials not increasing patient exposure or pulmonary toxicity risk in phase 2. During phase 2.5, multicenter trials reopened and limited research staff were allowed on site. RESULTS: Despite initial enrollment declines during the early pandemic, the percentage of new patients enrolling in clinical trials from March to August 2020 was 8.8%, and represented a 10.5% relative increase from 2019. Monthly accrual enrollment from March to August 2019 ranged from 42 to 71, compared with enrollment during COVID-19 from 23 to 73 patients (P < .001). CONCLUSIONS: Through a phased approach to trial reopening and adaptive techniques, the division of radiation oncology maintained cancer trial accrual during the COVID-19 pandemic. The experience may help centers maintain accrual, preserve clinical trial integrity, and minimize risk to patients and staff.
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spelling pubmed-79275922021-03-04 Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic Yeboa, Debra Nana Akinfenwa, Chidinma Anakwenze Nguyen, Jonathan Amaya, Diana de Gracia, Beth Ning, Matthew Cox, Victoria De, Brian Smith, Benjamin D. Lin, Lili Beddar, Sam Hoang, Hanh Koong, Albert Liao, Zhongxing Adv Radiat Oncol Research Letter PURPOSE: Clinical trial enrollment has declined globally as a result of the coronavirus disease 2019 (COVID-19) pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently. METHODS AND MATERIALS: We report the effect of a phased trial reopening strategy, remote research staffing, and telemedicine on cancer trial enrollment at one of the largest radiation oncology academic cancer centers. In phase 1, trials investigating definitive therapeutic benefit were opened, followed by trials not increasing patient exposure or pulmonary toxicity risk in phase 2. During phase 2.5, multicenter trials reopened and limited research staff were allowed on site. RESULTS: Despite initial enrollment declines during the early pandemic, the percentage of new patients enrolling in clinical trials from March to August 2020 was 8.8%, and represented a 10.5% relative increase from 2019. Monthly accrual enrollment from March to August 2019 ranged from 42 to 71, compared with enrollment during COVID-19 from 23 to 73 patients (P < .001). CONCLUSIONS: Through a phased approach to trial reopening and adaptive techniques, the division of radiation oncology maintained cancer trial accrual during the COVID-19 pandemic. The experience may help centers maintain accrual, preserve clinical trial integrity, and minimize risk to patients and staff. Elsevier 2021-03-03 /pmc/articles/PMC7927592/ /pubmed/33686374 http://dx.doi.org/10.1016/j.adro.2021.100676 Text en © 2021 The Authors https://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 Research Letter
Yeboa, Debra Nana
Akinfenwa, Chidinma Anakwenze
Nguyen, Jonathan
Amaya, Diana
de Gracia, Beth
Ning, Matthew
Cox, Victoria
De, Brian
Smith, Benjamin D.
Lin, Lili
Beddar, Sam
Hoang, Hanh
Koong, Albert
Liao, Zhongxing
Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
title Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
title_full Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
title_fullStr Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
title_full_unstemmed Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
title_short Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
title_sort effectively conducting oncology clinical trials during the covid-19 pandemic
topic Research Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927592/
https://www.ncbi.nlm.nih.gov/pubmed/33686374
http://dx.doi.org/10.1016/j.adro.2021.100676
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