著者
高柳 理早 山田 安彦 河野 真理子 中村 均 佐藤 均 伊賀 立二
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.28, no.5, pp.489-494, 2002-10-10 (Released:2011-03-04)
参考文献数
5
被引用文献数
1 1

The new Good Clinical Practice (GCP) guidelines, which were based on ICH-GCP, were enforced in Japan in April 1997. These guidelines recommend that pharmacists play the role of managers of investigational drugs and also as cooperators (clinical research coordinator) in the performance of clinical trials. In this study, we carried out a survey of the attitude of the new graduate pharmacists (the group of graduates in the 1998 fiscal year and a group of graduates in the 1999 fiscal year) on clinical trials. After the first questionnaire, we lectured the students on GCP and performed clinical trials, and then the second questionnaire was conducted two months later. The group of graduates in the 1999 fiscal year had more opportunities to come in contact with information on clinical trials than the group in the 1998 fiscal year. Both groups knew that new GCP guidelines had been established, but they did not understand the details. Some of them had a negative impression concerning clinical trials. The lectures improved their knowledge and impression on the practice of clinical trials. After the lecture, over 90% of them thought that pharmacists should manage investigational drugs and provide information on these drugs for the rational practice of clinical trials. Furthermore, in 60% or more of the students, an improvement in the consciousness of evaluating the safety and efficacy of investigational drugs regarding the pharmacist's role was found.