ABSTRACT
Objective: This study summarizes the practical experience of remote monitoring in clinical trials, preliminarily discusses the advantages and consideration factors, and provides reference for monitoring and management of clinical trials. Methods: In view of the problem that on-site monitor cannot be conducted on time during the COVID-19, our hospital launched the online remote monitoring system in time relying on the DPAP technology for the use of sponsor and CRO. The application of remote monitoring by September 15, 2020 were counted through the system backstage. The effect of application was objectively evaluated by comparing the defect detection rate per subject found by remote monitoring and on-site monitoring with chi-square. The user experience, advantages and disadvantages of remote monitoring system were investigated through homemade questionnaire and in-depth interview. The method of health economics evaluation was used to estimate the cost of simple on-site monitoring mode, remote monitoring and on-site monitoring combined mode. Results: The hospital officially launched the remote monitoring system on February 10, 2020. Until September 15, 2020, 176 CRAs from 76 sponsors/CRO have used the remote monitoring system for totally 10 470 times to conduct remote monitoring, involving 228 projects, 1 318 subjects, 16 departments in our hospital. A total of 3 820 findings have been found during the remote monitoring of 228 trials. Compared with the on-site monitoring of the same project in 2019, the remote monitoring achieved the on-site monitoring effect in terms of checking protocol deviation, case report form (CRF), combined drug use and biological samples;however, it is not as good as the on-site monitoring in terms of original records, informed consent, adverse events and experimental drugs, which involves more paper materials. 72.61% of CRAs believed that remote monitoring system effectively supported the completion of monitoring work, and 62.50% of CRAs thought that it reduced the time of on-site monitoring. The in-depth interviews with 16 CRAs showed that remote monitoring had advantages and was highly praised. The cost of the combination of routine on-site monitoring visit, remote monitoring and on-site monitoring was calculated, resulting that on-site monitoring visit frequency was reduced by 16 times, saving 73 600 RMB of travel expenses and 624 hours of travel time. But remote monitoring should be considered and standardized in system verification, subject informed consent monitoring and privacy protection, data security, implementation and other aspects. Conclusion: The remote monitoring mode made the monitoring free from location and time constraints, timely found the problems in the trials, greatly improved the efficiency of the monitoring, and reduced the risk and cost of clinical trials. In the future, it can be applied and explored in more aspects, but still needs to be further supplemented with data sources and standardized in the aspects of system verification.