Vol.3 No.4 2011

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Talk : Clinical research and synthesiology−302−Synthesiology - English edition Vol.3 No.4 (2011) (Higuchi)It means that the drugs that can be used in other countries cannot be used in Japan, because the system of clinical trial is insufficient here.(Moderator)The basic researches for medicine were very active in the United States, and then they started talking about translational research. Was that because the genetic researches came into focus?(Higuchi)There was a great breakthrough where suddenly there were potentials for application of genetic analysis. If the genetic studies did not go far, the bioscience researches might not have been stimulated as much today.(Moderator)The reductionist explanation now reaches the level that allows synthesis. That is the world of elementary particles in physics, and it’s genes in medicine. Because we were able to uncover the element of the mechanism, now people can offer new ideas.(Higuchi)How can things be quickly shifted over to clinical research? This is certainly a background for the emergence of translational research.However, many psychiatric disorders and chronic lifestyle-related diseases such as diabetes are the results of combination of genetics and environment, and they are very complex systems.What is necessary to promote clinical research(Moderator)Although the importance of shifting from basic research to clinical research is understood by society, in Japan, there is no training for the translation part, and there are also issues with the researchers’ awareness. Is there hesitation for a researcher or a physician engaging in basic research to shift to clinical research?(Higuchi)I’m sure there are interests. However, if one wishes to do so, one must put the main job aside. Particularly, since it is difficult for a researcher to venture out to the site of clinical practice, a team is necessary. Since it is difficult for a researcher to become directly involved in clinical trials, it is necessary to create a team of researchers and clinical practitioners who share a common thinking, mediated by someone in the role of a clinical research coordinator (CRC).(Ono)Will that be the role for the national institutes or the independent administrative agencies?(Higuchi)I think so. The National Center that harbors large-scale research institutes and a hospital fits well in the role. It is necessary to form a team where the members play their respective roles and work together toward a common goal. The National Center has stated that we are eager to take that role. I think it is difficult for a university to do that since they act by laboratory units.I don’t think there are many organizations that are capable of conducting everything from start to goal, from creating a product in their labs and then verifying the product in clinical situations.(Ono)A pharmaceutical company with very large capital can design everything from research to clinical practice, and then conduct large-scale clinical research, can’t it?(Higuchi)The research institutes of the Japanese pharmaceutical companies are very competent, and have excellent ideas to create new compounds. Yet these compounds cannot be verified in Japan. They are taken to foreign countries, and then are re-imported to Japan as drugs.(Moderator)From the standpoint of pharmaceutical companies, are there barriers in conducting clinical trials in Japan?(Higuchi)I guess the Japanese clinical trial system is both time-consuming and expensive. For example, when a new drug is taken to the United States, the first step will be completed in half a year, while it takes two years in Japan. In that case, it is better that the first step be completed in the States and the drug be re-imported. In terms of market, Japan has a population of 120 million or so, China has 1.3 billion, Dr. Motoyuki Akamatsu

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