薬理と治療

Clinical Research Data Management, often called CDM has grown into a mature profession. This article reviews that development. A proposed set of clinical research data management goals are articulated. The scope of practice is defined according to established professional competencies in clinical data management and informatics. CDMs of the future will need to command a wide array of tools and methods applicable to data collection and use in clinical studies. Graduate education will likely become an entry point to the profession.

The Ethical Guidelines for Clinical Research mandate the monitoring of invasive intervention studies to secure the reliability. Monitoring is also mandatory for specified clinical trials in Clinical Trials Act. In academia, establishing a monitoring system that can be implemented with limited resources is essential. In this study, we present a feasible monitoring system that will secure a certain level of quality while being implemented in an investigator‒initiated clinical trial（corresponding to a multicenter, double‒blind, comparative, and specified clinical trial）. This monitoring system is implemented through a combination of several factors such as: developing a monitoring plan that considers the research implementation system of the institution, creating monitoring work support tools, providing practical monitoring education for personnel who already belong to research institutions, and outsourcing some operations to the Clinical Research Organization（CRO）. In this way, a monitoring system that can be implemented even with limited resources, can be developed.

A rubric was introduced to facilitate the training of CRAs（clinical research associates）efficiently and smoothly at innovative Clinical REsearch center, Kanazawa University（iCREK）, and it was very useful as a learning and assessment tool. We hope that it will serve as a reference when nurturing CRAs at other medical institutions.

The Clinical Trials Act became effective on April 1, 2018, as a result of several scientific misconduct issues, and brought a major shift in clinical research in Japan. Although the clinical research monitoring is required by the law, many investigators at Kanazawa University Hospital（KUH）hardly understand how to manage the monitoring duties by themselves. Therefore, we surveyed the current situation of understanding of the clinical research monitoring by the investigators at KUH. We sent 10 monitoring managers of 18 pieces of clinical researches conducted by KUH a questionnaire and obtained 7 number of questionnaire respondents. All the respondents were medical doctors, and 5 of them had experienced principal investigators in some other clinical researches. Furthermore, 5 of 7 respondents had experienced some clinical trials. On the other hand, all of the respondents had no experience in clinical monitoring previously. Because of that, all of them poorly understood the monitoring work and showed great concern for the accomplishment of clinical monitoring duties by themselves. These suggest that clinical research monitoring is a special skill even from clinical researchers who had experienced principal investigators. We revealed that the investigators of clinical research needed some kind of support for clinical monitoring. We have been constructing a system to support the investigators by doing the monitoring duties and holding a seminar and training periodically. By thoroughly performing notification of our system, we will continue to support even more to ensure the quality and authenticity of the clinical research.

Background　Recruiting participants for clinical trials（CTs）has been an arduous task for those conducting the trials. Patient factors likewise physician ones have affected participating for CTs, we investigated perceptions and attitudes of patients, to consider solutions for recruiting participants in CTs. Methods We used the web‒based survey data of perceptions to cancer clinical trials which 2,102 subjects responded via internet between May to June 2016. The questionnaire probed attitudes towards clinical trials including perception and provision of information for CTs. We analyzed the differences in attitudes to CTs among several responder attributes. Results　Patients who have good impression, feel beneficial, and not feel anxious to participating in CTs tended to ask for the information of CTs compared with patients who do not. Moreover, from the results by correspondence analysis, dimension 1 was termed“scientific and social/sentient perception”and the second dimension“positive/skeptical perception”. Scientific and social perception was tendency strong among 20s and 60s, sentient perception was tendency strong among 70s. Conclusions　Differences in the perception for CTs among several responder attributes. Contents of information and the way of communication in CTs should be considered according to patient health literacy, though information of CTs had been provided patients in point of view on health care professional.

Background　While conducting statistical analyses in global drug development, statisticians and programmers across regions may face challenges due to the differences in regulation, language, and geographic region. This article proposes a process that facilitates appropriate and timely implementation of statistical analyses and regulatory responses. Methods　Based on the experience of US and Japanese pharmaceutical companies in conducting global clinical trials and submitting new drug applications, we propose a process for implementing statistical analyses and regulatory responses irrespective of the locations of study team members. The process is based on gap analyses of regulations and practices regarding statistical analyses between regions, including consideration of different requirements for tables, listings, and figures between the Pharmaceuticals and Medical Device Agency（PMDA）and Food and Drug Administration（FDA）. Results　Through efficient resource utilization and early planning, Japanese and US teams were able to successfully deliver datasets and analyses for both PMDA and FDA submissions in a timely manner with high quality based on the proposed process. Conclusions　A well‒defined process improves the efficiency and quality of PMDA submissions using global clinical trials. The current proposal facilitates the appropriate and timely conduct of statistical analyses using the Clinical Data Interchange Standards Consortium standards for global clinical trials and new drug applications.

Several surveys of the impact of the Clinical Trials Act have been previously conducted. However, they were mainly focused on pharmaceuticals, rather than on medical devices. We conducted two kinds of surveys in order to investigate the impact of the Clinical Trials Act on clinical research that uses medical devices. One was a call for opinions in the Japan Society of Clinical Trials and Research website （Period: October 1 to November 30, 2018）, and the other involved surveys and opinions from 12 Certified Clinical Trials Review Boards（CRBs）of the Clinical Research Core Hospitals（Period: August 21 to September 6, 2019）. The surveys showed concern that medical devices, which have significantly different characteristics from those of pharmaceuticals, were nevertheless, treated the same way. Medical devices are extremely diverse, and it is difficult to secure human resources capable of responding to them in each CRB and, therefore, to review them all. It was also desired to prepare guidance and support tools（like flowcharts）to facilitate judgments, and to implement informational activities. The Clinical Trials Act was designed centered on pharmaceuticals and does not necessarily correspond to the characteristics of a wide variety of medical devices. In clinical research using medical devices, there is strong demand for a more appropriate institutional design that covers clinical research based on their characteristics, such as the risk classification of medical devices.

Objectives　Our primary objective was to promote nurses’ involvement in clinical research. To this end, we studied training nurses’ experience with and awareness of clinical research. We then used this information to establish methods for the education of clinical research among nurses. Methods　We surveyed clinical nurses at Tokushima University Hospital and assessed their awareness of clinical research knowledge using questionnaires. We used five‒point and two‒point scales for the same. We included questionnaires that collected data on various experiences, and the participants’ awareness and experiences were analyzed using descriptive statistics. Results　All 23 of the nurses who participated in Tokushima University Hospital’s nursing training program responded to the questionnaires（response rate: 100％）. Approximately 80％ of the respondents were aware of registration trials and clinical research, but less than 20％ of the nurses were aware of the difference between the two and of the ethical aspects of clinical research. Although the roles of a clinical research coordinator were not recognized, 26％ of the nurses showed an interest in clinical studies and the nursing of clinical trial participants. Conclusions　These finding suggested that nurses’ level of knowledge related to clinical research was not sufficient. Based on these results, we would be able to examine and formulate possible educational implementations in a future study.