Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Sep 5, 2022
Date Accepted: Jun 7, 2023
Reducing Clinical Trial Monitoring Resource by hybrid monitoring model in clinical trials: A retrospective study from Peking University Cancer Hospital
ABSTRACT
Background:
Given the monitoring challenges existing during the epidemic situation, Peking University Cancer Hospital timely launch the remote monitoring system and establish a monitoring model combining on-site monitoring and remote monitoring in clinical trials. Considering the inevitable and promising trend of digitization of clinical trials, it is very important to explore an optimal clinical trial monitoring model to provide reference and insight for other centers of clinical trial worldwide.
Objective:
To summarize the practical experience of the hybrid model of remote monitoring and on-site monitoring of clinical trials, and to provide a reference for clinical trial monitoring management.
Methods:
We recruited 201 trials that used on-site monitoring alone or a hybrid monitoring model in our hospital. Through the monitoring reports of these trials from June 20, 2021 and June 20, 2022 and a s customized questionnaire was developed to collect and compare the following information: the monitoring cost of trials, the differences in the monitoring frequency, average volume of monitored documents, and time consumption between the routine on-site monitoring and the hybrid monitoring model.
Results:
Data from the remote monitoring system of our hospital as from June 20, 2021 to June 20, 2022 indicated, there were 320 monitors from 201 sponsors in our hospital who ever used the remote monitoring system for remote source data review and verification on 3299 subjects in 320 trials. We recruited a total of 201 trials, which were 91 trials of on-site monitoring alone (Arm A) and 110 trials with a hybrid model of remote monitoring and on-site monitoring(Arm B). Arm A trials were monitored 728 times using the on-site monitoring alone, and Arm B trials were monitored 849 times in total using on-site monitoring and remote monitoring approaches during 6/20/2021 and 6/20/2022. On average, the number of all visits in which the subjects could complete the review per monitoring in the hybrid monitoring model increased by 34% compared with the traditional model, the length of monitoring decreased by 13.8%, and the total cost decreased by 38.5%. The non-parametric test showed that the difference was statistically significant (P < 0.05).
Conclusions:
The hybrid monitoring model can timely detect the issues of the trials, greatly improve the monitoring efficiency, reduce the cost of clinical trials, and can be applied and explored in more aspects in the future. Clinical Trial: Not Applicable
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.