, Hiroshi TANAKA

Abstract. The purpose of this study is to clarify the benefit and loss for the pharmaceutical companies when they adopt introducing pharmacogenomics in their clinical trials (in the following description, clinical trials by using pharmacogenomics is called "pgx clinical trial"), that is, when they use genetic information in their clinical trials. Particularly, the benefit for the pharmaceutical companies in terms of following two points is analyzed. 1. Development cost of new drug and period of clinical trial can be reduced because a clinical trial needs less subjects, 2. The new drug can be placed on the market earlier because the development period can be shortened. A survey conducted by Japan Pharmaceutical Manufacturers Association revealed that the pharmaceutical companies in Japan are interested in "pgx clinical trial". Specifically, 95 % of the member companies (n=19) of the Association replied that the establishment of a guideline for pgx clinical trial by regulatory authorities are highly desirable. However, 65 % of them (n=13) also replied that pgx clinical trial is difficult for the time being.It can be concluded that the pharmaceutical companies are positiv