ABSTRACT
<b>Background:</b> Re-revision of the Ethical Guidelines for Clinical Study (EGCS) in Japan is planned in 2013. It is important to ascertain the current situation of physicians' understanding to conduct clinical trials. It seems that the difference in regulatory processes between commercial and non-commercial clinical trials has caused significant confusion for physicians in conducting clinical trials in Japan.<br>This survey was undertaken in order to improve awareness of the differences between both types of clinical trials. Furthermore, this survey examined whether it was effective to promote about clinical trials under newly introduced regulatory guidelines and to examine the subsequent willingness of physicians to conduct such clinical trials.<br><b>Methods:</b> From 24<sup>th</sup> March to 24<sup>th</sup> April 2009 inclusive, a questionnaire survey was conducted targeting 286 physicians working at Shiga University of Medical Science Hospital. A follow-up survey was conducted among 109 participants at a lecture about clinical trials on 8<sup>th</sup> July 2009.<br><b>Results:</b> Physicians who had prior knowledge of the regulations, purposes, or support systems for commercial and non-commercial clinical trials responded positively that they were more likely to conduct clinical trials, while physicians who had no prior knowledge of them responded negatively. Both groups reported that their daily working pressures and cumbersome regulatory processes prevented them from conducting clinical trials.<br><b>Conclusion:</b> Japanese physicians lack knowledge and information about clinical trials, leading to negative perceptions and reduced willingness to conduct such studies. Thus, the introduction of any strict and complex regulations should be approached carefully when the environment for clinical trials has not yet been established.
ABSTRACT
Abstract Combined treatment with high-dose methylprednisolone and Kampoherbal medicine (Xiao-Chai-Hu-Tang and Jia-Wei-Gui-Pi-Tang) brought about a striking clinical improvement in a 24-year-old woman with severe hepatitis-associated aplastic anemia. Laboratory findings on admission were summarized as follows: granulocytes 325/μ<i>l</i>, erythrocytes 2, 450, 000/μ<i>l</i>, platelets 10, 000/μ<i>l</i>, bone marrow nucleated cells 27, 000/μ<i>l</i>, and GPT 569IU/<i>l</i>. Neither anti-lymphocyte globulin, high-dose methylprednisolone alone nor oxymetholone was effective on any hematological finding although intravenous administration of high-dose glycyrrhizin improved the liver dysfunction. The patient needed repeated transfusions of leukocyte-poor washed red blood cells and HLA-matched platelet concentrates for a period of 1.5 years until the hematopoietic function recovered 3 months after combined treatment with high-dose methylprednisolone and Kampo-herbal medicine. Laboratory findings on discharge were as follows: granulocytes 1, 050/μ<i>l</i>, erythrocytes 3, 460, 000/μ<i>l</i>, reticulocytes 100, 000/μ<i>l</i>, platelets 47, 000/μ<i>l</i>, bone marrow nucleated cells 118, 000/μ<i>l</i>, and GPT 52IU/<i>l</i>. Six months later hematopoietic depression recurred, and this combined treatment was performed again with favorable response.