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

临床试验设计数据库建设及个人信息保护安全系统开发

基本信息

批准号：
17606001
负责人：
HAYASHI Doubun
金额：
$ 2.3万
依托单位：
The University of Tokyo
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
2005
资助国家：
日本
起止时间：
2005 至 2006
项目状态：
已结题

项目摘要

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.

临床试验需要大量参与者经过长时间的跟踪，以及大量的金钱和劳动力，特别是在与生活方式相关的疾病或其他心血管疾病方面。许多研究的结果，特别是那些阴性结果的研究结果没有公布。这一趋势在那些由制药公司赞助的公司中尤其如此。因此，即使数据有用，医学界或普通公众也无法获得这些发现。这种情况最近导致了海外国家强制进行临床试验注册。在日本，几个临床研究注册网站也开始出现。在这些网站上，关于临床研究的信息应该被公平地提供，无论是否定的还是积极的发现。考虑到上述情况，我们在本研究项目中进行了以下工作：1)我们开发了一个可在网络上注册的临床试验设计数据库，这使得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。2)我们建立了一个网站，介绍了由永井良三编辑的《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和密码的认证系统外，我们还研究了采用指纹认证技术在两个网站上进行注册和日志管理，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，认为指纹认证系统在未来的临床试验中无论从安全性还是用户友好性方面都是必要的。