薬理と治療

Randomized controlled trials have been usually used for drug evaluation of efficacy, but not of safety（e. g. increased risk of adverse events induced by a drug）. Evaluation of drug safety is mainly based on spontaneous reports of adverse events and pharmacoepidemiological research using huge medical information database. In this article, we describe progress and future direction of two projects about utilization of medical information for drug safety evaluation in Japanese pharmaceutical regulatory agency. One is the MIHARI Project which is a new framework for pharmacoepidemiological research using various database and the other is the MID‒NET(R) which is the new infrastructure for analysis of medical records data in many hospitals.

Background and Purpose Since 2009, we have performed allocation support for randomized controlled trials conducted by on‒campus researchers in the Kitasato Clinical Research Center. Recently, because high‒quality scientific research practices are required, randomized control trials conducted by on‒campus researchers and consequent allocation work requests to our center have increased. Because work requirements differ among studies, including methodologies and implementation environments, issues regarding work quantity and complexity, like personnel shortage, have arisen. To improve efficiency, in 2014, we constructed a random allocation automation system（KiRS）for web‒based allocation registration. We have provided allocation support via KiRS for some clinical studies since March 2014. In this study, we examined the utility of KiRS by investigating subject registration status and surveying users. Methods Based on the allocation registration log, we investigated registration status before and after introduction of KiRS（allocation until November 30, 2014）. Regarding KiRS usage, we surveyed principal researchers of clinical studies（5 cases）that performed allocation support via KiRS. Results Monthly average of registration status before and after introduction of KiRS（5.46±4.77 and 5.88 ±5.48 cases, respectively）did not show a notable change. Average work duration shortened from 6.3±4.0 min/case to 1.5±1.0 min/case before and after introduction of KiRS, respectively. An average response of“good”was obtained from subjects regarding usage simplicity and clarity. Conclusion Because registration status was unchanged after introduction of KiRS, KiRS was not considered to have a major impact. However, because overall work duration of users and of allocation personnel was reduced, KiRS was considered a useful allocation system.

Tanaka et al（2014）reported most of biostatistical consultation in Japanese medical institutes was not operated as an official service according to standardized operation procedures but often conducted as voluntary work. Then we developed biostatistical consulting operation procedures at National Center for Global Health and Medicine, Tokyo, Japan, which were based on the results of a survey on biostatistical consulting at Japanese medical institutes. Here we next show the consulting results done from January 2014 to December 2014 according to the standard operation procedures we developed, and compare consulting results with other two medical institutes.

Project management （PM）skills and knowledge are very important in the development of drugs and medical devices. In this study, we examined the role of PM skills and knowledge in effectively conducting clinical studies. We conducted a web‒based questionnaire survey on project managers and members of clinical study projects in the drug industry or academia. Based on the result of this study, we recommend the use of PM tools and technology in academia, to accelerate the development of Japan‒derived drugs and medical devices. In addition, we found that the education of project managers in the medical field, both in the industry and academia, was important. Improvement of the management skills of project managers and the PM knowledge of project teams is vital for the effective management of clinical projects, and is the key to lead a project to successful completion.