Vol.3 No.4 2011

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Talk : Clinical research and synthesiology−301−Synthesiology - English edition Vol.3 No.4 (2011) to promote translational medicine for the clinical research in psychiatry, neurology, myology, and developmental disorder.Why Japan has fallen behind in large-scale clinical researches(Moderator)As in the case of muscular dystrophy you mentioned earlier, there are several basic researches that may offer ideas for therapies. But still there are not a lot of applications to clinical practice. Including large-scale clinical research, why has Japan fallen so far behind in clinical research?(Higuchi)A researcher is evaluated for his work of “publishing high-quality, original researches in high-quality journals”. A large-scale clinical research can only be conducted by a team of perhaps 40 people, and it involves extremely careful design and preparations, as well as recruiting many patients. This is extremely unproductive for a researcher. It may take five to six years to complete a single clinical research. Moreover, even if a wonderful result is obtained, there is only one first author. For the other 39 people, considering the efficiency of their energy spent, it is much more efficient to design a trial alone, conduct research in a few months using animals, yield results, and become the first author to publish in Nature or Science. While it is understandable for the people to think this way, it is one of the reasons that this field has not advanced. In the United States, research funds and human resources are allotted, and there could be multiple authors who are evaluated for participating in the research. I think there are differences, and Japan has definitely fallen behind.(Moderator)The background for falling behind in large-scale clinical research seems to be similar to our situation, i.e. the motivation to launch Synthesiology. What do you think, Editor in Chief?(Ono)Dr. Higuchi mentioned that one of the reasons for being left behind in clinical research is the problem of “paper productivity in research”. At AIST, when we tried to focus on Type 2 Basic Research as a bridge spanning between Type 1 Basic Research and Product Realization Research, we were requested, “Please evaluate us as researchers. There is no journal in this field. What should we do?” That is why Synthesiology was created. Although it is still in its dawn, we have been thinking hard how the papers published in this journal are different from the papers of what we called basic science, and what makes them original. Also, we disclose the name of the reviewers. With ordinary academic journals, the tendency is to keep the reviewers anonymous, and the names of the authors are apt to be hidden to the reviewers to maintain the fairness. We did the opposite. We disclosed what points were given credit and what points were not. We ensured transparency. In fact, this worked positively in terms of fairness. Because the names of reviewers are disclosed, they cannot ask careless questions or make biased comments.(Moderator)Are there other reasons that prevent the advancement of clinical research?(Higuchi)As a nation, the government has not placed importance on clinical research, has not provided funds, or trained human resources.The pharmaceutical companies engage in large-scale clinical research, but they are limited to the cases where there are many patients who may eventually use the product. Serious diseases with fewer patients require support of the government. The recently started “clinical trials sponsored by investigators” are conducted mainly by physicians through public research funds, without the direct involvement of the pharmaceutical companies.In terms of training human resources, the education system is still insufficient. To conduct clinical research, we need specialists in biostatistics and epidemiological statistics, but there are hardly any courses at the universities. Therefore, most people study abroad and return to work at pharmaceutical companies. To conduct large-scale clinical research, one must design it on how many cases are needed to obtain the required statistical significance. However, there are only about five university courses for clinical epidemiology. Even though the researchers may be motivated, there was no environment for clinical research, and its importance was not shared by the government, university, or research institutes. As a result, Japan was left far behind.(Ono)Sometimes I hear the phrase “drug lag”.Dr. Akira Ono

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