Abstract
In order to present good clinical data with conclusive evidence, a multi-institutional cooperative clinical study is essential. In this paper we report on how to conduct a multi-institutional clinical study in Japan. When constructing a study group of investigator-initiated clinical trials, standardization of diagnosis, indication, and treatment is very important. Support systems for clinical trials at Tokai University are presented and problems in cooperation among multiple institutes are discussed. Preparation of the infrastructure, motivation of researchers, and funding are the most important factors.
