JMIR Publications

ABSTRACT

Background:

The COVID-19 epidemic and ensuing public health policies to restrict virus transmission have had major impacts on the conduct of oncology clinical trials, and there is a lack of strategy to deal with this situation.

Objective:

To explored the management strategies to minimize the impact of the COVID-19 epidemic on oncology clinical trials.

Methods:

We explored the remote management model in maintaining the clinical trials of the Beijing Cancer Hospital through two COVID-19 outbreaks in the capital city, in 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 85.24% for 3,718 subjects across both outbreaks. No 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:

During public health emergencies, an optimal clinical trial management model could guarantee the health and treatment needs of clinical trial subjects, with the remote clinical trial model playing a key role. Clinical Trial: This was a retrospective study that did not require online registration.