Abstract P20: Continuity of oncology clinical trials during the Coronavirus Disease-2019 pandemic in Korea

Abstract

Abstract Coronavirus-19 outbreak caused concern of lowering performance of clinical trials, including delays in initiation, lower enrollment, or more frequent deviations related with visit schedule change. Korea, with the sixth largest number of industry-sponsored interventional drug trials in the world, has been controlling COVID-19 outbreak rather successfully and maintaining daily medical practice in most areas of the country. We investigated performance of oncology clinical trials before and after COVID-19 in Korea. We retrospectively identified and reviewed the files, notes, and source documents of ongoing breast cancer clinical trials during January to May 2019 and January to May 2020 in a single cancer center conducting oncology trials in Korea. Number of enrolled patients, drop-outs, protocol deviations including study visit delay or visit omission were measured. We investigated 77 ongoing studies from January to May 2020, and 67 from the same period in 2019. The numbers of newly initiated trials and new enrollment were not decreased during COVID-19 outbreak period. After outbreak of COVID-19, number of onsite monitoring was decreased, however total number of monitoring was maintained as remote monitoring was increased. Remote monitoring comprised 44% of all monitoring visit in 2020, and found 30%(15/50) of protocol deviations detected by all monitoring visit. Of the 26 study visit related protocol deviations during February to May 2020, 10(38%) cases were COVID-19 related. Thirteen percent(3/24) of study drop out cases were COVID-19 related, from subjects’ demand due to fear of visiting hospital. Although monitoring access was limited, vigorous countermeasures successfully maintained performance of oncology clinical trials during COVID-19 outbreak in Korea. Remote monitoring visits successfully complemented restricted onsite monitoring. COVID-19 related protocol deviations and drop-out cases were noted, mostly from subjects’ concerns about travel. Future regulations and guidelines should pursue developing alternatives of face-to-face contact visit as needed. Citation Format: Hee Kyung Ahn, Soohyeon Lee, Seon-A Jang, Ji-Yeon Kim, Jin Seok Ahn, Yeon Hee Park. Continuity of oncology clinical trials during the Coronavirus Disease-2019 pandemic in Korea [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2021 Feb 3-5. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(6_Suppl):Abstract nr P20.