In order to improve the situation of, and to grow up the clinical research in Japan, it is necessary that the doctors in all clinical fields should understand the basic subjects in relation to clinical research. Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) has been recognized to have the responsibility to establish the education system on this fields. This time we have carried out the questionnaire survey on the education in relation to the clinical research by the clinical Societies in the Japanese Board of Medical Specialties. The answers from 58 societies (82%) have shown that more than 90% of the societies expect to establish the standardized education program on clinical research in Japan, and have admitted that the clinical specialists in each field have to have the knowledge on clinical research. From these results the several members of JSCPT and other medical organizations in cooperation have established the Physicians' Education Council of Japan for Clinical Trial (PECJCT) on behalf of Dr Fumimaro Takaku as the president.

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The pharmacokinetics and pharmacodynamics of eltrombopag, a thrombopoietin receptor agonist developed for idiopathic thrombocytopenic purpura, were investigated in healthy Japanese adult males after single and repeat doses of eltrombopag in two clinical studies.
In the first study, subjects received a single oral dose of eltrombopag tablets at 30, 50, 75 and 100mg and placebo in the fasted state. In the second study, each subject received single and once daily for 10 days repeat doses of eltrombopag (25, 50 or 75mg) or placebo tablets. Plasma eltrombopag concentrations and platelet counts were measured in both studies. AUC and C_max were proportional to dose within the range of 30-100mg. The AUC_0-24 values after repeat doses of eltrombopag 25, 50 and 75mg were 56, 130 and 161μg·hr/mL, respectively, increasing nearly proportionally to the dose increase. The plasma concentration reached steady state in approximately 7 days after starting the repeat dose, and the change in pharmacokinetics caused by repeat dose was small. The AUC values obtained after single and repeat dose in Japanese subjects were nearly two-fold higher than those previously reported in non-Japanese subjects (predominantly white).
No significant changes in platelet count were observed after single oral doses up to 100mg of eltrombopag. When 25, 50 and 75mg were administered once daily for 10 days, the maximum increase in platelet count from the baseline was 54%, 72% and 90%, respectively, showing a dose-dependent increase. These increases were higher as compared with the previously reported increases in platelet count observed after 30, 50 and 75mg were administered once daily for 10 days to non-Japanese healthy adults. The increase in platelet count from baseline became higher with increasing AUC in Japanese healthy adults.
These results suggest that the difference in platelet count increase between Japanese and non-Japanese is probably associated with the observed inter-ethnic difference in AUC. Eltrombopag might be used at a lower dosage in Japanese than in non-Japanese to attain similar degrees of platelet count increase.

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Informed consent (IC) is an essential ethical requirement for conducting clinical trials. This study aimed to investigate changes in research on IC for clinical trials and compare the trend in Japan with that overseas.
In February 2010, the electronic databases, PubMed and Japana Centra Revuo Medicina were searched for studies on IC for clinical trials both in and outside Japan.
The literature search identified 89 Japanese studies and 401 overseas studies concerning IC for clinical trials. In Japan, these articles were first published in 1993, and the number increased remarkably from 2002. Many of these articles discussed the contribution of a clinical research coordinator or the understanding of the information by trial subjects. The overseas studies were first published in the early 1980s, and the number increased remarkably in the 1990s.
Since, the enforcement of the new Good Clinical Practice in 1998, observational studies on IC for clinical trials have been conducted in Japan. However, most of these studies applied a quantitative approach, and qualitative analysis is limited. In Japan, IC is not focused exclusively on the protection of trial subjects, but also serves as the basis for an important encounter to build the physician-patient relationship. Therefore, investigations of the IC process by qualitative and quantitative approaches are necessary.

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Objectives: In this study, we surveyed the methods of subject recruitment used in medical institutions and investigated the appropriate methods for each type of clinical study or medical institution.
Methods: We conducted a questionnaire survey regarding the methods of subject recruitment used in four medical institutions (Department of Clinical Research, National Cerebral and Cardiovascular Center; Clinical Trial Center, Shiga University of Medical Science Hospital; Center for Drug & Food Clinical Evaluation, Osaka City University Hospital; Translational Research Center, Kyoto University Hospital) in November 2009. We listed the methods of subject recruitment indicated in the responses and determined the suitability for specific target diseases or medical institutions based on the possibility of increasing the number of subjects or promoting registration of subjects.
Results: Different methods aiming at facilitating recruitment were used depending on the target disease and the situation of the medical facility. These methods include advertising within the institution using audiovisual materials, putting information of the study on a web page, forming a volunteer group, and explaining the clinical study separately from outpatient consultation.
Conclusion: It is necessary to select and combine methods of subject recruitment depending on target disease and situation of the medical facility.

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