Abstract
In Japan, clinical trials have been so far based on approval initiated by pharmaceutical companies. Investigator-initiated clinical trials have not yet been established.
In this situation, the Translational Research Informatics (TRI) Center was established in Kobe city, Japan, under the Kobe Medical Industry Development Project, in order to support and promote clinical research. The TRI center consists of some research departments, the Department of Clinical Trial Management, the Department of Clinical Genome Informatics, and so on. The Department of Clinical Trial Management (DCTM) is involved in tje organization of clinical trial teams, design of clinical trials, protocol development, and statistical analysis of trial results.
Chemoradiotherapy has been used in an effort to improve therapeutic results for locally advanced, non-resectable head and neck cancer. Improved local-regional control and disease-free or overall survival have been shown in several randomized trials using a concurrent or an alternative approach. Further clinical trials are needed to clarify the most suitable combination of chemotherapy and radiation.
In this paper, the organization of DCTM is introduced as an example for successful clinical trials, and the necessity of team-based clinical trials is discussed.
