TY - JOUR
T1 - Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic
AU - Yeboa, Debra Nana
AU - Akinfenwa, Chidinma Anakwenze
AU - Nguyen, Jonathan
AU - Amaya, Diana
AU - de Gracia, Beth
AU - Ning, Matthew
AU - Cox, Victoria
AU - De, Brian
AU - Smith, Benjamin D.
AU - Lin, Lili
AU - Beddar, Sam
AU - Hoang, Hanh
AU - Koong, Albert
AU - Liao, Zhongxing
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/5/1
Y1 - 2021/5/1
N2 - 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.
AB - 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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U2 - 10.1016/j.adro.2021.100676
DO - 10.1016/j.adro.2021.100676
M3 - Article
C2 - 33686374
AN - SCOPUS:85112865043
SN - 2452-1094
VL - 6
JO - Advances in Radiation Oncology
JF - Advances in Radiation Oncology
IS - 3
M1 - 100676
ER -