2017 年 48 巻 1 号 p. 15-20
Drug development in Japan is very important to the nation from the point of view of providing the highest level of medical care in Japan. Grouping multiple medical institutions to form a large clinical trial network is indispensable for drug development with respect to improvement of case recruitment. Showa University has eight affiliated hospitals in Tokyo and Kanagawa with a total of 3,200 beds, and is engaged actively in the promotion of clinical trials and clinical research. From July 2012, the Showa University Hospital Clinical Trial Support Center played a leading role to coordinate with the Clinical Trial Support Offices of the eight affiliated hospitals, holding a clinical trial support joint meeting once every three months. A working system was established for standardization of formats and costs as well as joint operation of the IRB, eventually leading to the establishment of a clinical trial network for the eight hospitals of Showa University. Also, a large number of clinical studies that can only be conducted in the university hospital setting have been conducted. Education on clinical trial and clinical research is important not only for medical staff including physicians, dentists, pharmacists, nurses, and laboratory technicians, together with students of medical sciences, but also for staff outside medical institutions including pharmaceutical companies. In this article, we report the issues encountered and their solutions while constructing the clinical trial network for eight hospitals of Showa University. Furthermore, we propose the future challenges of this network, which we hope will provide a reference for other organizations.
