Establishment of the MID‐NET^® medical information database network as a reliable and valuable database for drug safety assessments in Japan

Abstract

PurposeTo establish a new medical information database network (designated MID‐NET®) to provide real‐world data for drug safety assessments in Japan.MethodsThis network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID‐NET® is a distributed and closed network system that connects all collaborative organizations through a central data center. A wide variety of data are available for analyses, including clinical and administrative information. Several coding standards are used to standardize the data stored in MID‐NET® to allow the integration of information originating from different hospitals. A rigorous and consistent quality management system was implemented to ensure that MID‐NET® data are of high quality and meet Japanese regulatory standards (good post‐marketing study practice and related guidelines).ResultsMID‐NET® was successfully established as a reliable and valuable medical information database and was officially launched in April 2018. High data quality with almost 100% consistency was confirmed between original data in hospitals and the data stored in MID‐NET®. A major advantage is that approximately 260 clinical laboratory test results are available for analysis.ConclusionsMID‐NET® is expected to be a major data source for drug safety assessments in Japan. Experiences and best practices established in MID‐NET® may provide a model for the future development of similar database networks.

The utilization and challenges of Japan's MID‐NET® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

“…More accurate analyses may be possible by defining objective clinical outcomes using these laboratory test results, which have generally been unavailable in conventional claims databases. These pilot studies were conducted during MID‐NET ® 's construction phase, and the available data were therefore limited at that time . After its official implementation in April 2018, the sample sizes will be expected to increase with time.…”

“…However, the database network is not without limitations in its current form . First, the patients included in this database may tend to have relatively severe conditions in the acute phase.…”

“…It should be noted that the number of partner hospitals that participated in each pilot study was different, since these pilot studies were conducted during the establishment of MID‐NET ® and the maximum number of partner hospitals available at the time of the data extraction and analysis was selected based on the study design and data period. All analyses in the pilot studies were conducted using SAS9.4 (SAS Institute, Cary, North Carolina) for datasets extracted from MID‐NET ® .…”

“…This ordinance was recently amended on April 1, 2018, to permit the use of database studies (in addition to primary data collection studies) in postmarketing assessments required under the Pharmaceuticals and Medical Devices Law. In parallel, the Japan's Medical Information Database Network (MID‐NET ® ) was formally launched in April 2018 . It is expected to become a major data source for postmarketing drug safety assessments and promote an internationally harmonized approach to drug safety assessment based on real‐world data.…”

“…In parallel, the Japan's Medical Information Database Network (MID-NET ® ) was formally launched in April 2018. 8,9 It is expected to become a major data source for postmarketing drug safety assessments and promote an internationally harmonized approach to drug safety assessment based on real-world data.…”