Strategic Proposal on Clinical Research - Towards Fundamental Changes of Clinical Research Systems in Japan -/CRDS-FY2006-SP-08
Executive Summary

Japan has invested a substantial amount of money in basic life sciences research and accumulated a wealth of knowledge. However, because the system to implement clinical research is not strong enough and there are problems with the review and approval agency, it has been difficult to lead the results of fundamental research quickly to practical use. These problems for clinical research have been pointed out before, awareness of the problems has been shared among the concerned people and each related government office has been promoting various measures for improvement. However, Japan is still lagging behind Europe and the United States in terms of swiftness and efficiency of putting the results of fundamental research into practical use.
While to make drastic reform of the systems to approve clinical research and review/approve it and establish a system that quickly enables the research and development of new drugs and medical devices are pressing policy issues, there is a limit only with the efforts of the related government offices alone and it is time for us to make national commitment to addressing these issues. Although there are many policy issues, the following two are most important and require urgent response. We propose that these issues should be set into action as quickly as possible.

1. Establishment of a Basic Law on Clinical Research (provisional title)
To establish the “Basic Law on Clinical Research (provisional title)” that includes the following contents, formulate “basic plan” based on this and strongly promote government-led clinical research.
1) Basic policies on clinical research promotion
2) Establishment of headquarters for clinical research promotion
3) Roles of the government, the review and approval agency, colleges, physicians, and industries
4) Measures to promote clinical research
5) Improvement of the system of the review/approval agency
6) Promotion of public understanding
7) To state that the government should formulate a basic plan for clinical research

2. Establishment of a Clinical Research and Development Complex and building of a network of clinical research facilities
It is necessary to establish a well-organized research center to promote clinical research, namely “Clinical Research and Development Complex”. The “Complex” will consist of the following three sections: Clinical Research Promotion and Support Center; a hospital where clinical research is conducted, and an Advanced Medical Research Development Center. In the “Complex,” clinical studies targeting humans shall be first implemented accurately and efficiently. To build a “Clinical Research Network” that links clinical research implementation sites across the nation such as universities and national hospitals with a high-speed information system, centering on the “Complex,” form the cooperation structure of clinical research implementation sites in Japan and strongly carry out the nation-wide clinical research. To inject human resources and funds into the “Complex” and position it as the core base of clinical research in Japan.

Once the above systems are built, the following social effects can be expected: (1) the public can receive the latest and high-quality medical care, which realizes a healthy and long-life society, (2) the research and development efficiency for new drugs and medical devices will be improved, promoting and revitalizing international competitiveness of medical industry in Japan, and (3) all of which lead to reduce the economic burdens of the public.