医療薬学
Online ISSN : 1882-1499
Print ISSN : 1346-342X
ISSN-L : 1346-342X
新卒薬剤師の治験に対する意識調査
高柳 理早山田 安彦河野 真理子中村 均佐藤 均伊賀 立二
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2002 年 28 巻 5 号 p. 489-494

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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.

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