Establishment of new modality of treatment, diagnosis and prevention of various diseases is an important role of university hospital. In this article, restrictions and guidelines for clinical investigations in Japan are reviewed and supporting system for promotion of clinical trials, now being organized at Tokushima University Hospital, is introduced.
The main division in the supporting system of clinical trials is the Clinical Trial Center for Developmental Therapeutics. It was first organized as the Clinical Trial Center for New Drugs and Therapeutic in 1999 under the leadership of Prof. Saburo Sone. Five nurses work as clinical research coordinator (CRC) and coordinates close communication among participants, sponsor and investigators, and plays a crucial role in the efficient progress of clinical trials. Pharmacists and officers also contribute for promotion of clinical trials in the center.
The supporting field is now being expanded from the support for clinical trial for drug approval to clinical trials conducted by investigators. For example, one pharmacist supports technically the project of dendritic cell-based vaccination against various malignancies in newly-constructed room.
Based on the experience, our task is to grow the center to academic research organization. We are now dealing the following issues ; 1) promotion of clinical trials conducted by investigators, 2) scientific clinical trials of food, 3) setup of network of clinical trials in Tokushima prefecture with general physicians and other institutions
