Abstract
BackgroundIn view of repeated COVID-19 outbreaks in most countries, clinical trials will continue to be conducted under outbreak prevention and control measures for the next few years. It is very significant to explore an optimal clinical trial management model during the outbreak period to provide reference and insight for other clinical trial centers worldwide.ObjectiveThe aim of this study was to explore the management strategies used to minimize the impact of the COVID-19 epidemic on oncology clinical trials.MethodsWe implemented a remote management model to maintain clinical trials conducted at Beijing Cancer Hospital, which realized remote project approval, remote initiation, remote visits, remote administration and remote monitoring to get through two COVID-19 outbreaks in the capital city from February to April and June to July 2020. The effectiveness of measures was evaluated as differences in rates of protocol compliance, participants lost to follow-up, participant withdrawal, disease progression, participant mortality, and detection of monitoring problems.ResultsDuring the late of the first outbreak, modifications were made in trial processing, participant management and quality control, which allowed the hospital to ensure the smooth conduct of 572 trials, with a protocol compliance rate of 85.24% for 3718 participants across both outbreaks. No COVID-19 infections were recorded among participants or trial staff, and no major procedural errors occurred between February and July 2020. These measures led to significantly higher rates of protocol compliance and significantly lower rates of loss to follow-up or withdrawal after the second outbreak than after the first, without affecting rates of disease progression or mortality. The hospital provided trial sponsors with a remote monitoring system in a timely manner, and 3820 trial issues were identified.ConclusionsWhen public health emergencies occur, an optimal clinical trial model combining on-site and remote management could guarantee the health care and treatment needs of clinical trial participants, in which remote management plays a key role.
Highlights
COVID-19 was recognized as a global pandemic on March 11, 2020 [1,2]
Efforts to stem the spread of SARS-CoV-2 led to isolation measures and travel restrictions that have severely hindered the smooth conduct of clinical trials [3]
It seems likely that as COVID-19 outbreaks repeatedly occur in many countries, clinical trials will continue to be conducted under public health emergency conditions for some time to come
Summary
COVID-19 was recognized as a global pandemic on March 11, 2020 [1,2]. Efforts to stem the spread of SARS-CoV-2 led to isolation measures and travel restrictions that have severely hindered the smooth conduct of clinical trials [3]. 1 (page number not for citation purposes) obvious decreases in the numbers of participants newly enrolled participants: protocol compliance rate, rate of loss to follow-up, in trials, and many oncology clinical trials were suspended in rate of participant withdrawal, rates of disease progression and. It seems likely that as COVID-19 outbreaks repeatedly occur in many countries, clinical trials will continue to be conducted under public health emergency conditions for some time to come. The conduct of oncology clinical trials will be challenging, given that such trials usually require many follow-up visits and sophisticated monitoring of complex disease courses [9,10]. Insights into how to optimize oncology clinical trial management during public health emergencies are urgently needed. In view of repeated COVID-19 outbreaks in most countries, clinical trials will continue to be conducted under outbreak prevention and control measures for the few years. It is very significant to explore an optimal clinical trial management model during the outbreak period to provide reference and insight for other clinical trial centers worldwide
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