Construction of clinical trial management system used for multi-center trial

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Number of clinical trials has not been increased after introduction of Good Clinical Practice (GCP) in Japan. Multi-center trial is expected to increase the number of clinical trials. However, there are several problems to conduct clinical trials in Japan. It is hard to know how many patients are expected to enter the clinical trial before the start of the clinical trial. First, we constructed a system to know how many patients who match the requirements of the clinical trials such as age, gender, diagnosis, disease stages, clinical examination or diagnostic imaging. Since there is a considerable diversity between the hospitals in the level of introduction of hospital information system (HIS), we tried to extract minimum information from HIS. The extracted information was stored in the server and can be accessed by Internet. The minimum system can be used in various hospitals with various levels of computerized medicine. Next, we constructed a system which enabled to extract in-depth clinical information in the University hospital, where highly sophisticated HIS was introduced. It would be expected to construct high performance system, if such high-function HIS was introduce to every hospitals. Next, we tried to construct a system to exchange information on patients between hospitals that entered multi-center trials. We made a system to send information on entry to a clinical trial and to serve the data on the patients. We plan to expand the system to deal with the data of follow-up referred to the patients. When multi-center trial starts, it is important which hospitals to enter the trials. To assist to the decisions, we studied situation of hospital-to-hospital coordination and medical service area of each hospital by using geographic information system (GIS). GIS clarified which hospitals is to be entered multi-center trial.