Construction of Clinical Trail Designs Database and Development of Security System for Personal Information Protection

临床试验需要大量的受试者长期随访，以及大量的资金和劳动力，特别是在生活方式相关疾病或其他心血管疾病方面。许多研究结果，特别是那些阴性结果的研究结果没有发表。这一趋势在制药公司赞助的项目中尤为明显。因此，即使数据有用，医学界或公众也无法获得这些结果。这种情况最近导致海外国家强制临床试验注册。在日本，也开始出现了几个临床研究注册网站。在这些网站上，临床研究的信息应该被公平地提供，无论是阴性还是阳性结果。考虑到上述情况，我们在本研究项目中进行了以下工作。1）我们开发了一个可通过网络访问的数据库，用于注册临床试验设计，这使得有关临床试验的基本信息能够公平地提供给医疗保健专业人员和公众。我们建立了一个网站，介绍了永井良三编辑的心血管疾病临床研究摘要中包含的约250项已发表的临床试验。3）除了使用用户ID和密码的身份认证系统外，还研究了在两个网站的注册和日志管理中采用指纹认证技术，以加强信息系统的安全性。我们还研究了在实际临床试验中引入该技术的可能性。从安全性和用户友好性的角度来看，我们认为指纹认证系统在未来的临床试验中是必要的。

Clinical trials require large numbers of participants followed over long periods of time, as well as a large amount of money and labor, especially in lifestyle-related diseases or other cardiovascular diseases.The results of many studies, particularly those with negative findings are not published. This tendency is particularly true of those sponsored by pharmaceutical companies. Consequently, the findings are not available to the medical community or the general public, even if the data is useful. This situation has recently led to compulsory clinical trials registration in overseas countries. In Japan, several web sites for registration of clinical studies begin to emerge as well. On these web sites, information about clinical studies is supposed to be fairly provided, regardless of the negative or positive findings.Considering the above situation, we conducted the following in this research project.1)We have developed a web-accessible database for registration of clinical trial designs, which enables basic information about clinical trials to be provided fairly to healthcare professionals and the public.2)We have set up a web site that introduces about 250 published clinical trials included in the Summary of Clinical Studies in Cardiovascular Diseases edited by Ryozo Nagai. Text mining capabilities have been added to the system with keyword searches.3)In addition to authentication system using user IDs and passwords, we have studied about the adoption of fingerprint authentication techniques for registration and log management in the both web site to strengthen security of information system. We have also investigated the possibility of introduction of the techniques in actual clinical trials.It is believed that fingerprint authentication systems are necessary in conducting clinical trials in the future in terms of both security and user-friendliness.