2023 Volume 54 Issue 1 Pages 9-16
Background/Aims: Many physician-initiated clinical trials not for approval have been conducted in Japan, but vulnerable quality management was unmasked with the finding of misconduct in trials. While monitoring has become mandatory with the implementation of the Clinical Research Act of Japan, the errors occurring in such trials were not fully recognized. The aim of the present study was to clarify errors through early, risk-adapted, on-site monitoring of physician-initiated clinical trials involving patients with cardiovascular diseases.
Methods: Early, risk-adapted, on-site monitoring was undertaken at 15 hospitals where 3 multicenter, randomized, controlled trials that enrolled 884 patients were conducted. The selection of facilities was based on the results of early central monitoring. Monitoring items were selected according to the risk assessment of each trial. The errors detected including their effects on the quality of trials were described.
Results: Of the 176 cases monitored, 71 procedural and 13 recording errors, including 32 in the process of informed consent, 17 in the selection of patients, 17 in randomization, 6 in the trial intervention, 3 in the outcome measures, and 2 in reporting serious adverse events (SAEs), were identified. Nine of the procedural errors regarding informed consent, selection of patients, and randomization were considered serious, whereas all recording errors were not serious. The steering committee revised the study protocol and the standard operation procedure of one study to prevent these errors.
Conclusion: This risk-adapted, early monitoring triggered by central monitoring showed that a number of errors occurred in physician-initiated clinical trials, particularly, during patient enrolment, and such early monitoring might help investigators detect and address serious errors to improve the quality of ongoing clinical trials before they become uncorrectable.
