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

在日本引入药物临床试验质量管理规范（GCP）后，临床试验的数量并未增加。多中心试验有望增加临床试验数量。然而，在日本进行临床试验存在一些问题。在临床试验开始之前，很难知道预计有多少患者进入临床试验。首先，我们构建了一个系统，以了解有多少患者符合临床试验的要求，如年龄，性别，诊断，疾病分期，临床检查或诊断成像。由于医院信息系统（HIS）的引入水平在医院之间存在相当大的差异，因此我们试图从HIS中提取最少的信息。提取的信息存储在服务器中，可以通过Internet访问。最小系统可用于具有不同计算机化医疗水平的各种医院。接下来，我们构建了一个系统，该系统能够在引入了高度复杂的HIS的大学医院中提取深入的临床信息。如果将这样一个高性能的HIS系统引入到各个医院，就有望构建出高性能的HIS系统。接下来，我们试图构建一个系统，用于在进入多中心试验的医院之间交换患者信息。我们做了一个系统来发送进入临床试验的信息，并提供患者的数据。我们计划扩展该系统以处理转诊患者的随访数据。当多中心试验开始时，哪些医院进入试验是重要的。为了辅助决策，我们利用地理信息系统（GIS）研究了医院与医院之间的协调情况和各医院的医疗服务区域。GIS澄清了哪些医院将进入多中心试验。

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.