適正な治験実施のための治験コーディネーターの取り組みとその成果

Abstract

Clinical research coordinators (CRCs) play an important role in ensuring to that clinical trials are conducted in accordance with the new GCP guidelines. In Shimane University Hospital, the clinical trial coordination system was officially introduced in April 2002.In the present study, we carried out a survey on protocol derogation cases before (from April 1997 to March 2002) and after (from April 2002 to March 2005) the introduction of the system to evaluate the effectiveness of CRCs in improving the quality of clinical research in our hospital. In doing this, we investigated the details of the protocol derogation cases and the reasons for derogation. We also looked at the extent of adoption of the per protocol set (PPS) and full analysis set (FAS) by clinical trial sponsors.After the introduction of the CRC system, the following improvements were observed. The incidence of protocol derogation dropped to 1/3, a significant decrease. Patient noncompliance had accounted for 1/3 of all derogation cases before the introduction of the system but after introduction, there were no more cases of noncompliance. There were also no more of the violations of enrollment criteria, which was related to the extent of adoption of FAS and PPS. Adoption rates of FAS and PPS increased from 97.2% to 100% and from 88.9% to 93.4%, respectively. Any noncompliance cases that resulted in exclusion from PPS after introduction of the system were due to adverse events and other unavoidable causes.These results indicate that the activities of CRCs raised the quality of clinical trials in our hospital.