Under the Drug and Medical Device Safety Information Reporting System, medical and pharmaceutical professionals are required to report information about adverse drug reactions to the Minister of Health, Labour and Welfare of Japan. In this study, we aim to investigate classes related to this system in the universities with medical schools across Japan. We had asked the universities with medical schools, nationwide, to participate in the study. Then, we collected information from them on the courses related to this system. Of 82 universities in total, 32 universities （39.0％）responded with the contents of such courses and 11 universities（13.4％）responded that they have no such classes. The courses related to this system, included 15 pharmacology courses, 9 medical safety/management courses, 10 clinical pharmacology/pharmacotherapy courses, 8 hygiene/public health courses, and 19 other courses. The most common grade in which these courses were taught was the 4th year, and only two universities had these courses in the 5th and 6th years. There was only one course in which drug safety information report forms were actually “filled in” by the students. In the free description columns, there were relatively many responses referring to the importance of making the students understand the pharmacokinetic/pharmacological mechanisms of adverse drug reactions and the necessity for the improvement of understanding of drug-induced sufferings including history. In conclusions, the lectures of this system in the medical schools were mainly conducted in pharmacology and clinical pharmacology/pharmacotherapy courses. However, lectures in the 5th and 6th years were insufficient, and the number of courses in which practical training and exercises were conducted was limited.
To evaluate the bioequivalence of the generic product Azacitidine for injection 100 mg “Sawai” and the branded product Vidaza® for injection 100 mg, a two-period, two-way crossover study was conducted in 35 Japanese patients with myelodysplastic syndromes (MDS) who were being treated with azacitidine. The MDS patients were subcutaneously administered 100 mg (one vial) of either “Sawai” or Vidaza® on Days 1 and 2 within the same treatment cycle of azacitidine regimen. Plasma azacitidine concentrations were determined up to 4 hours after administration. Treatment with the patients' usual dose of Vidaza® was continued on and after Day 3.
AUCt and Cmax of both products were calculated from the plasma azacitidine concentrations up to 4 hours after administration on Days 1 and 2 to assess bioequivalence. The 90％ confidence interval of difference in the average values of the generic and branded products was within the acceptable range of log (0.80) ‒log (1.25) described in the Guideline for Bioequivalence Studies of Generic Products. All adverse events were confirmed as recovered or recovering at the time of last observation, and the safety profiles of both products were similar.
The results suggest that Azacitidine for injection 100 mg “Sawai” and Vidaza® are bioequivalent and therapeutically equivalent.
The role of a clinical research coordinator (CRC) is to support and facilitate clinical research activities, and thus the CRC plays a key role in conducting clinical research. Care for participants during the trial is a particularly important aspect of the CRC's responsibilities, but the difficulties and challenges involved remain unclear. This study aimed to clarify the issues related to care for participants from the perspective of CRCs by means of semi-structured focus-group interviews. The issues were extracted from verbatim data of the interviews by coding and categorization based on the KJ method. Sixteen CRCs participated in the study. There were 4 categories of issues; CRCs themselves, related to participants, doctors, and the environment. “Difficulty in interacting with participants” or “difficulty of explaining the trial to participants” were perceived as issues of CRCs themselves, and “participants' high expectations” or “participants' misunderstanding of clinical trials” were identified as issues of participants. In addition, “insufficient communication between participant and doctor”, “ambiguity in the division of roles between doctor and CRC”, and “differences in the expertise of CRCs such as nurses and pharmacists” were perceived as issues that affect care for participants. For CRCs, to efficiently fulfill their responsibilities, it would be necessary to resolve the multifaceted issues related to care for participants identified in this study.
Biobanks have been established in many countries worldwide for a couple of decades. The main research ethics issues related to biobanks that have been discussed include consent for biobanks; human biological sample, data transfer agreements, and their provisions; the absence of laws or regulations on biobanks, especially in Japan; and the sustainability of biobanks. To address these issues, we propose that the notion of custodianship, which has been discussed in Europe and the United States, is imperative and are of the opinion that this notion is intertwined with public trust related to handling human biological samples and data in biobanks. Given the concept of custodianship, we examined the traditional dichotomy of the provision of samples and data in biobanks in Japan: provision via joint research agreements and provision via samples or data transfer agreements (MTA or DTA). Consequently, we developed a new framework for the provision of biospecimens and data in biobanks, which is based on the notion of custodianship. Finally, we also noted the possibility that this Custodianship Model for biobanks can work in conjunction with the Charitable Trust model, which may provide a rationale for charging actual costs for provision by biobanks.