Recently, medical real world data involving claims data, drug data, and electrical medical record database have been developed worldwide and can be utilized for the phrmacoepidemiology research.The results of the pharmacoepidemiology research with these database contribute not only to post-marketing safety research but also to the outcomes research and pharmacoeconomic evaluation. On the other hand, collaborating with a number of local governments, we have developed maternal and child health check-up and school health check-up database in Japan. The development of healthcare lifecourse data like this will contribute to the preventive medicine, the understanding of the rare diseases, and drug development.

Background: Because of a severe shortage of clinical researchers in Japan, training clinical physicians to perform clinical research is an important issue in medical education. Although education has started to provide a foundation for clinical research, it is unclear whether clinicians, who should play a central role in a clinical research, are interested in performing clinical research and participating in a training program for clinical research.1) We performed a cross-sectional Internet survey to determine the interest of clinicians' interest in performing a clinical research and participating in a clinical-research training program.2) A total of 2176 clinicians were sent emails requesting their participation in this survey, and 310 responded (response rate, 14.6%). Eighty-five percent of the respondents were interested in conducting clinical research, and 78% were willing to participate in a clinical-research training program.3) Most respondents were willing to participate in a training program as part of an educational seminar or a training course after a few years of clinical practice. The respondents desired an educational system that would allow them to learn about clinical research while continuing their clinical practice.4) Although the rate of willingness to participate in a training program was highest (90%) among respondents who wanted to earn a doctorate, the rates were also high among those who did not want to earn a doctorate (76%) and those who had already earned a doctorate (74%).5) An educational system for clinical research should allow graduate schools to play leading role in training and should be flexible enough for clinicians who do not want to earn a doctorate.

Background: 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.
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.
Methods: From 24^th March to 24^th 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^th July 2009.
Results: 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.
Conclusion: 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.

Recently, medical real world data involving claims data, drug data, and electrical medical record database have been developed worldwide and can be utilized for the phrmacoepidemiology research.The results of the pharmacoepidemiology research with these database contribute not only to post-marketing safety research but also to the outcomes research and pharmacoeconomic evaluation. On the other hand, collaborating with a number of local governments, we have developed maternal and child health check-up and school health check-up database in Japan. The development of healthcare lifecourse data like this will contribute to the preventive medicine, the understanding of the rare diseases, and drug development.

Several studies have shown that low cardiorespiratory fitness (CRF) or heavy alcohol consumption is risks of total or certain types of cancer death. However, the combined influence of CRF and drinking habits on total cancer mortality is not clear. The purpose of this study was to investigate the joint effect of CRF and drinking habits on total cancer mortality among Japanese men. We evaluated the CRF and drinking habits on risk of total cancer mortality in 8,760 Japanese men (age: 19-59 yr) who were given a submaximal exercise test, a medical examination test, and questionnaires on their health habits. CRF was measured using a cycle ergometer test, and the men were classified into two categories by CRF levels based on the reference value of CRF (R-CRF) in “Physical Activity Reference for Health Promotion 2013” (Under R-CRF and Over R-CRF). Also, the men were assigned to Non Drinking, Moderate Drinking, and Heavy Drinking categories. There were 178 cancer deaths during the 20-yr follow-up period. Relative risk and 95% confidence intervals for total cancer mortality were obtained using the Cox proportional hazards model while adjusting for age, body mass index, systolic blood pressure, and smoking habits. Using the Under R-CRF & Heavy Drinking group as reference, the relative risk and 95% confidence intervals were 0.37 (0.16–0.85) for the Over R-CRF & Non Drinking group. This result suggests that Japanese male with a high CRF and a low drinking habit have a lower risk of total cancer mortality.

The promotion of clinical research in Japan requires the establishment of a formal and systematic education and training program for clinicians to ensure they become effective clinician investigators. The first of its kind in Japan, a formal 1-year masters-degree-level training program (MCR course) was started at Kyoto University School of Medicine and Public Health. The first 28 students graduated in 2008, with most returning to their original clinical institutions.
1) As follow-up, we conducted a self-administered questionnaire survey of all 28 graduates (response rate, 86%) concerning the current status of clinical research and problems encountered at their institutions.
2) Almost 40% of respondents (n=24) reported "no time" or "no research collaborators" for clinical research.
3) Twenty respondents (83%) have attempted to promote clinical research at their hospital or workplace, but only 1 has received institutional support.
4) Over half of the respondents (54%) would like to be working in both clinical research and clinical practice at their hospital in the future (10-year timescale). Forty-two percent of respondents had a concrete image of the clinical researcher's career path.
5) Although open to improvement, the MCR program presents a concrete model for the education of clinical researchers. These findings suggest that promoting the conduct of clinical research requires the implementation of a support system and adjustment of personal and physical infrastructure.

BACKGROUND: Recently, the prevalence of food allergies during childhood is increasing, with fruits being common allergens. However, data on allergens that cause fruit and vegetable allergies and pollen-food allergy syndrome (PFAS) in childhood are relatively few. This study aimed to examine the allergens in fruit and vegetable allergies in pediatric patients and to determine the association between fruit and vegetable allergies and PFAS.OBJECTIVE: This study aimed to examine the current status of fruit and vegetable allergies in Japanese children.METHODS: This was a multicenter case series observational study. The participants included children aged <15 years who developed allergic symptoms after eating fruits and vegetables and subsequently received treatment in the Pediatric Department of 6 hospitals in the Osaka Prefecture in Japan during the study period from August 2016 to July 2017. Participants' information was obtained using a questionnaire, and data were obtained by performing several types of allergy tests using blood samples.RESULTS: A total of 97 children (median age, 9 years; 56 males) were included in the study. Apple was the most common allergen, followed by peach, kiwi, cantaloupe, and watermelon. A total of 74 participants (76%) exhibited allergic symptoms due to PFAS; moreover, pathogenesis-related protein-10 (PR-10) was the most common allergen superfamily. On the contrary, in the group where neither PR-10 nor profilin was sensitized, kiwi and banana were the most common allergens, and the age of onset was lower than that in the PFAS group. Specific antibody titer was significantly associated with Birch for Bet v1 and latex for Bet v2 (r = 0.99 and r = 0.89).CONCLUSION: When we examine patients with fruit and vegetable allergies, we should first consider PFAS even in childhood specifically for children greater than 4 years old.
Age of Onset ; Allergens ; Asian Continental Ancestry Group ; Betula ; Child ; Citrullus ; Clinical Study ; Cucumis melo ; Eating ; Food Hypersensitivity ; Fruit ; Humans ; Hypersensitivity ; Japan ; Latex ; Musa ; Observational Study ; Prevalence ; Profilins ; Prunus persica ; Rhinitis ; Rhinitis, Allergic, Seasonal ; Vegetables

The Act for Eliminating Discrimination against Persons with Disabilities stipulates that medical training institutions need to offer the provision of Reasonable Accommodation to students with developmental disorders and/or related characteristics.　Reasonable Accommodation is the consideration to guarantee the rights of students with developmental disorders; thus, educational institutions have an obligation to provide this Reasonable Accommodation.　In this paper, we outlined specific support for students with developmental disabilities and related characteristics in medical training institutions from the aspects of “enrollment,” “university education,” and “employment.”　Essential ways to support students with developmental disorders and related characteristics include the presentation of clear criteria, mutual cooperation, and collaboration between faculty members and administrative staff, as well as understanding the basics of how to interact with such students.

Over the past 20 years, the Center for Medical Education Development Center, Gifu University has been working on training medical educators across the country. The Center offers a wide variety of programs to meet participants’ various needs and levels, targeting medical educators and administrative staff in various fields such as dentistry, pharmacy, nursing, physical therapy, and occupational therapy. This paper introduces the “Medical Education Starter Kit,” “Fellowship Program,” and “Master’s Course of Health Professions Education” among the programs. The objectives, target participants, and features of each program are outlined, including future prospects.