A Digital Network for Clinical Trials Involving Multiple Private Clinics in Japan

Enforcement of the new Good Clinical Practices enacted in response to introduction of the International Conference on Harmonization guidelines has brought about dramatic changes in clinical trials in Japan. The participation of private clinics is not yet permitted because of difficulty in handling adverse events, but it is expected that private clinics will eventually participate in clinical trials. This article describes a clinical trial system established at Togane Hospital. The system includes a clinical trial network that assists physicians who participate in clinical trials. To improve trial quality, we plan to introduce clinical research coordinators into private clinics, and to create an electronic case report form. Because we use the Internet for a variety of processes, including data collection and transmission, this system was designed as a virtual private network to ensure the consistency and security of data. The regional core public hospital functions as a site management organization in this network and supports the private clinics. The network aims to contribute to the improvement of regional medical care, and may be extended to clinical epidemiology to help develop evidence-based medicine in Japan.