九州大学病院における治験実施体制に関する依頼者を対象としたアンケート調査

Abstract

The Clinical Trial Management Center in Kyushu University Hospital was originally established in April 1999 and was later reorganized to form the Clinical Research Center in October 2003 due to the expansion of support activities for clinical trials. In pace with this, the number of clinical research coordinators (CRCs) increased from 2 in 1999 to 13 in 2005. To improve the performance of clinical research for physicians, CRCs and secretariats, we conducted a questionnaire survey of sponsors of clinical trials (pharmaceutical company staff) to see how they evaluated the work done by our Clinical Research Center. The questionnaire consisted of 10 items regarding our overall conduct of trial practice for which scores were obtained anonymously. We sent the questionnaire to 116 sponsor staff and received replies from 101 of them, a recovery of rate of 87%. The sponsors were generally satisfied with the conduct of clinical research at our Center, but were not fully satisfied regarding a few items which included the payment system for trial expenses, physicians' awareness, and recruitment of subjects by CRCs.Based on the results, we have recently introduced a new education system designed to increase physicians' motivation. Under this system, the conduct of clinical trials is limited to physicians who receive regular lectures on clinical research and are certified by our Clinical Research Center.