Sponsors’ Experiences with Site Management Organizations in Japan

In the past, clinical trials in Japan had a reputation for poor quality. Reasons for this poor quality included: I. Clinical trials were conducted at university and large hospitals where physicians were too busy; 2. There were no hospitals that specialized in clinical trials or support organizations, such as site management organizations; and 3. There were no clinical research coordinators. Under International Conference on Harmonization Good Clinical Practice, however, site management organizations and contract research organizations were created to facilitate clinical trials. Lately, interest in site management organizations and contract research organizations in Japan has grown. In order to conduct effective clinical trials, cooperation with site management organizations and contract research organizations is essential. This article summarizes the problems with clinical trials in Japan that must be solved and the current status of clinical trials. Two examples of experiences with site management organizations are described.