Vol.3 No.4 2011

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Talk : Clinical research and synthesiology−303−Synthesiology - English edition Vol.3 No.4 (2011) and India has 1.1 billion. That is why people are giving up development in Japan and going overseas. The hollowing out of clinical trial is an issue.Another point is that the capacity of the medical institution is very small. For example, if one wants to do a clinical trial with 100 cases, about 30 institutions must be contacted in Japan. In the United States or Europe, 10 to 15 cases can be done at one institution.(Moderator)Is that a matter of the size of the hospital?(Higuchi)Rather than the size, it is a matter of how much effort the medical institution is willing to spend on clinical trials. Now, the CRCs are distributed widely, and they can do all the paperwork while the physicians can concentrate on the evaluation. Before, the physicians had to do the paperwork themselves in addition to their clinical duties. They had to spend lots of time on it, and were limited in the extent they could cooperate.In 2008, the Science Council of Japan issued a statement called the “Issues of Clinical Trials in Japan and Future Measures”. They indicated the insufficiency of the clinical trial system in Japan as well as the extremely low incentive for the physicians to become involved. Making the situation worse, since the trials conducted overseas are done for the first time ever, they are published in relatively high-quality English-language journals, while the drug lag in Japan forces the researchers to do third-hand trials for which the result can only be published in minor journals. However recently, Japan is participating from the beginning in global trials, and at least the representative researcher is listed as one of the authors in the English-language journals.Incentive and support system for the researchers are necessary to promote clinical research(Moderator)Is writing papers the incentive for doing clinical research for the physicians at the universities and research institutions?(Higuchi)It’s papers and research funds. However, there are restrictions with research funds and it is very inconvenient.(Ono)There seems to be major problems, but how do you think they should be solved?Do you think the priority is to succeed with the Translation Research Center of the NCNP?(Higuchi)That is the priority. And then, we should provide motivation to the people involved in clinical research. A lot of energy is needed to carry out clinical research. To raise motivation, it is necessary to provide various incentives and to build a support system including coordinators. The TMC was created under the concept of transferring the results of the research institute to clinical practice, but the reverse is also necessary. This means that if a physician has an idea or wishes to do certain clinical research, we must be able to provide support, including helping with the design.(Ono)What do you think are the originality and interest of the translational research itself?(Higuchi)For the muscular dystrophy research I mentioned before, the first clinical application will be done at our hospital. The hospital is very cooperative because it is an original effort of the Center. The researchers are highly motivated because the research does not just end with discovery and they can be involved in the actual clinical application. However, when this study goes well, I wonder how many places will cooperate if we want to do research using several hundred cases throughout Japan. This will depend on the results of the clinical research sponsored by investigators.(Ono)So, in this clinical research sponsored by investigators, things can be taken from small-scale to medium-scale. Do you turn it over to the pharmaceutical company after that?(Higuchi)Yes, exactly.Research accepted and supported by society(Moderator)Since clinical research is a process where something is verified in society, I think the awareness that “it must be supported by the entire society” is necessary. If one behaves according to the values of the researcher alone, no one will help any large-scale trial. Don’t you think a shift in awareness of society is also necessary?(Ono)Also the attitude toward risks is important. The Japanese robot research is at quite an excellent level, but the last frontier is safety. The robot manufacturers become hesitant about product realization, because they think, with any accidents, “How much liability must we take?” or “Is it entirely the manufacturer’s fault?” I think it is similar for clinical trials. Is the risk taken entirely by the provider, or does the receiver or society agree to share the risk?

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