The effect of the contribution of clinical research coordinators in clinical trials at the Nagoya University Hospital

In order to carry out unitary management for the clinical trials of investigational drugs under Good Clinical Practice, the Center for Clinical Trial and Clinical Research was established at the Nagoya University Hospital in November 1998. Further, the clinical research coordinators (CRC) were organized in April 1999, and the general support of the clinical trial operation was started. Although it is well known that the involvement of CRC in clinical trials is necessary and important, the effect remains unclear. Thus, we evaluated the roles of CRC in the clinical trials of investigational drugs for rheumatic outpatients. The role of CRC includes assistance to obtain the informed consent, and to fill out the case report form, as well as management of the schedule. It was found that the rate of the consent acquisition from patients was significantly increased from 60.0% to 95.2% when CRC was involved. Further, the time to obtain agreement to enter into the clinical trials was significantly shortened and the rate (100.0%) of entry into the clinical trials supported by CRC was also higher than that (66.7%) in trials not supported by CRC. These results suggest that the informed consent from the patients can be obtained more easily when CRC is involved in clinical trials, and that such involvement of CRC contributes to an increase in the rate of entry of patients into the clinical trials and the speeding-up of the clinical trial enforcement.