Zhiying Fu1, Min Jiang1, Kun Wang1, Jian Li1. 1. Beijing Caner Hospital & Beijing Institute for Cancer Research, No.52 Fucheng Road, Haidian District, Beijing, CN.
Abstract
BACKGROUND: In view of repeated COVID-19 outbreaks in most countries, clinical trials will continue to be conducted under outbreak prevention and control 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 around the world. OBJECTIVE: To explore the management strategies to minimize the impact of the COVID-19 epidemic on oncology clinical trials. METHODS: We implemented the remote management model to maintain clinical trials conducted in Beijing Cancer Hospital, which realized remote project approval, remote initiation, remote visit, remote administration and remote monitoring to get through two COVID-19 outbreaks in the capital city during February-April and June-July 2020. The effectiveness of measures was evaluated as differences in rates of protocol compliance, subjects lost to follow-up, subject withdrawal, disease progression, subject mortality, and detection of monitoring problems. RESULTS: During the late of the first outbreak, modifications were made in trial processing, subject management and quality control, which allowed the hospital to ensure the smooth conduct of 559 trials, with a protocol compliance rate of 83.74% for 3,718 subjects across both outbreaks. No COVID-19 infections were recorded among subjects 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 one, 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. CONCLUSIONS: When encounter public health emergencies, an optimal clinical trial model combining on-site with remote management could guarantee the healthcare and treatment needs of clinical trial subjects, in which the remote management plays a key role.
BACKGROUND: In view of repeated COVID-19 outbreaks in most countries, clinical trials will continue to be conducted under outbreak prevention and control 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 around the world. OBJECTIVE: To explore the management strategies to minimize the impact of the COVID-19 epidemic on oncology clinical trials. METHODS: We implemented the remote management model to maintain clinical trials conducted in Beijing Cancer Hospital, which realized remote project approval, remote initiation, remote visit, remote administration and remote monitoring to get through two COVID-19 outbreaks in the capital city during February-April and June-July 2020. The effectiveness of measures was evaluated as differences in rates of protocol compliance, subjects lost to follow-up, subject withdrawal, disease progression, subject mortality, and detection of monitoring problems. RESULTS: During the late of the first outbreak, modifications were made in trial processing, subject management and quality control, which allowed the hospital to ensure the smooth conduct of 559 trials, with a protocol compliance rate of 83.74% for 3,718 subjects across both outbreaks. No COVID-19infections were recorded among subjects 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 one, 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. CONCLUSIONS: When encounter public health emergencies, an optimal clinical trial model combining on-site with remote management could guarantee the healthcare and treatment needs of clinical trial subjects, in which the remote management plays a key role.
Authors: Lucas Huret; Henri-Corto Stoeklé; Asmahane Benmaziane; Philippe Beuzeboc; Christian Hervé Journal: BMC Health Serv Res Date: 2022-05-25 Impact factor: 2.908
Authors: Katia Audisio; Hillary Lia; Newell Bryce Robinson; Mohamed Rahouma; Giovanni Soletti; Gianmarco Cancelli; Roberto Perezgrovas Olaria; David Chadow; Derrick Y Tam; Dominique Vervoort; Michael E Farkouh; Deepak L Bhatt; Stephen E Fremes; Mario Gaudino Journal: J Cardiovasc Dev Dis Date: 2022-01-10