Akaza Hideyuki, Ohashi Yasuo, Shimada Yasuhiro, Ikeda Tadashi, Saijo Nagahiro, Isonishi Seiji, Hirao Yoshihiko, Tsuruo Takashi, Tsukagoshi Shigeru, Sone Saburo, Nakamura Seigo, Kato Masuhiro, Mikami Osamu, von Euler Mikael, Blackledge George, Milsted Bob, Vose Brent
Dept. of Urology, Institute of Clinical Medicine, University of Tsukuba, Japan.
Gan To Kagaku Ryoho. 2002 Nov;29(11):2037-48.
Evidence Based Medicine (EBM) is a growing concept in Japan as it is elsewhere. Central to improving the use of EBM is generation of data through well conducted controlled clinical studies. There are many problems associated with conduct of clinical studies after launch in Japan, and many initiatives are ongoing to improve the situation. Development of Clinical Research Coordinators (CRO) and central Data Management centers are key to improving the quality of clinical research in Japan. Currently Japan has an undeveloped legal system with regard to post-launch trials and off-label use of registered drugs. There is no reimbursement for off-label and various restrictions imposed on the recipients of the Ministry of Health, Labour and Welfare's (MHLW) funds. Maybe the biggest problem is the high cost of post-marketing studies sponsored by pharmaceutical manufacturers. A high quality system to support post launch clinical studies need a solid financial base. There is a need for a suitable review system for investigator initiated multi-centre studies, as the current IRB system is not sufficient. There are also challenges regarding the differences, perceived or real, in treatment practice and available registrations in Japan and in the West, causing problems in choosing suitable comparators and study designs. At the present time it is not clear whether investigator initiated trials will be acceptable for registration purposes in Japan. The agreed first priority is to build a suitable and strong infrastructure within the academic community to support researchers to investigate important questions with or without pharmaceutical company support. Despite all these issues, several groundbreaking projects are under way throughout Japan, in many different areas and by different collaborative groups, some with government support. In fact, researcher-initiated clinical trials achieved a rapid growth in Japan in the past year.
循证医学（EBM）在日本如同在其他地方一样，是一个不断发展的概念。提高循证医学应用水平的核心在于通过精心开展的对照临床研究来生成数据。在日本，临床研究启动后存在诸多相关问题，目前正在开展许多举措来改善这种状况。临床研究协调员（CRO）和中央数据管理中心的发展是提高日本临床研究质量的关键。目前，日本在已上市药品的上市后试验和药品未注册用法方面的法律体系尚不完善。药品未注册用法没有报销，而且对接受厚生劳动省（MHLW）资金的对象有各种限制。也许最大的问题是制药商赞助的上市后研究成本高昂。一个高质量的支持上市后临床研究的系统需要坚实的资金基础。对于研究者发起的多中心研究，需要一个合适的审查系统，因为当前的机构审查委员会（IRB）系统并不充分。在日本和西方，治疗实践和现有注册情况在认知上或实际中存在差异，这也带来了挑战，在选择合适的对照和研究设计时会产生问题。目前尚不清楚研究者发起的试验在日本是否会被接受用于注册目的。首要任务是在学术界建立一个合适且强大的基础设施，以支持研究人员在有无制药公司支持的情况下研究重要问题。尽管存在所有这些问题，但日本各地许多不同领域的不同合作团体正在开展一些开创性项目，其中一些得到了政府支持。事实上，在过去一年里，研究者发起的临床试验在日本实现了快速增长。
