Vol.3 No.4 2011

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Talk : Clinical research and synthesiology−300−Synthesiology - English edition Vol.3 No.4 (2011) (Ono) I think that the discussion about the basic medicine and the clinical research may lead to the analogy of the Type 1 and Type 2 Basic Researches. There are dreams in the pure basic research, and the researchers who attained their dreams may win Nobel Prizes and receive research funds fairly easily. There is a great gap in terms of time and technology, however, for the basic research results to become actual products in industry and to be used in society. I think that some synthetic and integrating approaches are necessary for the basic research results to become valuable to society.(Higuchi) If Type 2 Basic Research is what is called application research, I think the researches that involve animal models and diseased cells can be positioned as such. The large-scale clinical research where humans are used as subjects is close to Product Realization Research. I think there is a shortage of research on how to get the products out to society. For example, considering anticancer drugs, one may induce cancer in an animal and prove that the cancer disappears when a certain drug is administered. However, it will not be a “drug” unless it is proven that it really works in humans and that there are no side effects.(Moderator) In the sense that it is a way of studying the therapeutic effect using human subjects, can clinical research be categorized as disease-oriented research? Is it like clarifying the disease mechanism?(Higuchi) The approach may be a bit different from mechanism clarification. Both pathological research and therapy research use humans as subjects. For example, to study the pathological condition of the Alzheimer’s disease, in the past, we could only look at the brain tissue of the deceased patient under the microscope. Now, with the advancement of imaging technology, we can look directly at the brain image of the living patient to study the pathological condition of Alzheimer’s disease. While this is a pathological research using human subjects, it is not therapy research. Therapy research falls in the domain of clinical research.(Moderator) Up to the pathological research, the mechanism of a natural phenomenon called the disease is clarified, and that may be close to Type 1 Basic Research. When this knowledge is converted to therapy, it turns into Type 2 Basic Research.TMC bridges the pathological study and the therapy(Ono) In the field of medicine, does a researcher engage in either the pathological research or the therapeutic one? Or can a researcher engage in all from the pathological to therapeutic researches?(Higuchi)Both cases are possible. Let me talk about an example of the study carried out at NCNP. It had been known that muscular dystrophy was a genetically transmitted disease, and a gene called dystrophin was finally discovered by a researcher. After more than ten years we are able to see what kind of abnormal proteins are produced and how they cause the muscles to atrophy. Now the researcher is trying to get to the therapy research.(Moderator)Looking at the Japanese clinical research statistics that Dr. Higuchi showed us, I am concerned that the number of Japanese papers published in four journals of basic medicine research with high impact factor (2000~2005) is ranked number four in the world, while Japan ranks eighth in the three clinical medicine research journals, and there are less number of papers.(Higuchi)Even if there is an accumulation of excellent papers in basic research, we are not getting the application in clinical practice. We are becoming aware that it is not right that we are unable to produce results that are actually useful to people. On that point, I think we share a common concern with AIST.NCNP is composed of a hospital and two research institutes. In the past, the institutes were mainly involved in basic research, and there was hardly any contact with the hospital that engages in daily clinical practice. However, when we were organized as an independent administrative agency, the consciousness that we should engage in the researches covering “from basic research through application research to clinical research” has risen in the past five to six years. As a move, the Translational Medical Center (TMC) started in 2009. TMC places the importance on linking the research and clinical practice, and to support clinical trials and researches Dr. Teruhiko Higuchi

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