In Japan, the basic research in life sciences is being actively pursued, and its quality is consistently high enough to provide many globally valuable findings. On the other hand, the clinical research lags far behind that in the United States and Europe in the efficacious and prompt development of new medical products and devices or technology due to a shortage of trained research professionals and less organized implemental system. This situation leads to a delay of providing the latest medical information to the people, to a loss of global competitiveness of the medical industries, and to slow upgrade of the medical technology in the institutions in this country. Considering that our society is rapidly aging, this is a really serious situation. This is why the Council for Science and Technology Policy has focused on to promote clinical research as an important subject in the 3rd Science and Technology Basic Plan, and the industry, government and academia partners are now working together to engage actively in this reform process.
For the reform process to succeed, establishing a well-organized clinical research system and developing future leaders of the clinical research have to be achieved as soon as possible. The Ministry of Health, Labor and Welfare draw up and published the New 5-year Plan for Clinical Trial Activation on March 2007 and the 5-year Strategic Plan for Innovative Medicine and Medical Devices on April 2007, and in both plans "education with regard to clinical research" has been highlighted as a significant important factor. The Ministry of Education, Culture, Sports, Science and Technology (MEXT) has also started carrying out the human resource development program on the science and technology promotion adjustment cost.
As for clinical research education, it is important to have an effective system particularly targeted to physicians to provide systematic education about clinical studies including clinical trials. This would make it possible for them to earn the essential knowledge and skills they need to have as clinical study professionals. By gaining practical experiences, they are expected to acquire the abilities to conduct efficacious clinical studies and to perform high level assessment of clinical study results.
Japanese Center of Pharmaceutical Medicine (JCPM) is a nonprofit organization established aiming to educate people about clinical studies including clinical trials in a systematic manner. Our plan is to provide education opportunity to wide variety of people such as healthcare providers including physicians, and people engaged in medical product development and regulatory review by collaborating with relevant academic communities and members. We hope our activity will contribute to development of future leaders in clinical research in Japan and consequently to promote the development of new medicines, medical devices and future technology.
Hiroo Imura
Chairman, Board of Directors
JCPM