Enteral feeding is commonly performed in medical and nursing care facilities. Enteral feeding takes a long time ; therefore, the dosing of drugs indicated for postprandial administration is always challenging clinics that lack knowledge of the potential effects of enteral tube feeding on clinical pharmacokinetics. In this study, the effects of enteral tube feeding on the pharmacokinetics of loxoprofen and cefcapene were investigated in a parallel group study design, in which Group I (N＝7) received loxoprofen (fine granules, 120 mg) and cefcapene pivoxil hydrochloride (fine granules, 100 mg) co-administered 15 min before the start of 120 min tube feeding with 400 mL of Ensure Liquid^®. Group II (N＝7) received test drugs during (i.e., 60 min after the start of) 120 min tube feeding, and Group III (N＝7) received the test drugs after (i.e., at the end of) 120 min tube feeding. The C_max of loxoprofen and cefcapene were statistically higher in Group I when the drugs were administered 15 min before tube feeding. The C_max of loxoprofen in Group I was 58.7% and 82.8% higher than that in Group II and Group III, respectively. The C_max of cefcapene in Group I was 43.3% and 32.2% higher than that in Group II and Group III, respectively. Although the AUC_∞ appeared to be similarly higher in Group I, no significant difference was observed between the 3 groups. However, these changes did not appear to be critically meaningful in the clinic. Administration of loxoprofen and cefcapene in patients under enteral tube feeding should be clinically manageable.

Osaka University Hospital has recently received many applications for clinical trials that involve genome analysis. Prior to review by the Institutional Review Board (IRB) of the hospital, these genome analyses are classified into groups A, B, or C, as defined by the Japan Pharmaceutical Manufacturers Association (JPMA), in accordance with the study purpose, target gene, and analysis schedule within the research. The IRB reviews the protocols and written informed consent forms in accordance with the GCP Ordinance and Ethical Guidelines for Human Genome and Genetic Analysis Research. At Osaka University Hospital, disagreements sometimes occur regarding the A, B, and C classification between the sponsors and the IRB. In the present study, we found that 24 applications that include genome analyses were judged as C by the IRB of our hospital, while they were judged as A, B, or even as a no genome analysis by the sponsors. We also conducted a questionnaire survey among other IRBs in Japan to find out their review policies for genome analyses. The questionnaire survey results revealed wide differences among IRBs in their review policies. Centralization of the IRB is currently being promoted to improve the efficiency and quality of ethical review of clinical trials. However, the establishment of a central IRB system requires standardization of the classification of genome analysis and review policies. In addition, sponsors should prepare protocols that clearly state the purpose and procedure of the planned genome analysis, and the hospitals where clinical trials are performed should consider an appropriate review system.

A statistical software delivery system was developed and operated by the Office for Promoting Medical Research in Showa University to support data analysis in medical research for the staff in the departments and hospitals of the University. We report our experience for fiscal year (FY) 2014 to 2017. There were 2,224 downloads of statistical software by the system during this term. The numbers of downloads and inquiries from the users were 425 and 3, respectively, in FY 2014; 513 and 8 in FY 2015; 600 and 29 in FY 2016; and 686 and 42 in FY 2017. The mean number of inquiries was small, about 4 inquiries per one hundred downloads. The administrator of this system could easily respond to 85 percent of all inquiries through email or telephone. This software delivery system seems to be efficient and helpful to researchers. The number of academic sections to support medical research in Japan tends to increase. Given the limitations in human resources and budgets in each institute, utilization of informatics technology such as our system would be useful and cost-efficient to support research activities.