This article aims to introduce the Real World Database-a new clinical database in Japan. The Health, Clinic, and Education Information Evaluation Institute and Real World Data Co., Ltd. began developing the Real World Database in 2015. This is an electronic medical record database linked to claims data and discharge abstract data from medical institutions in Japan. The institutions agreed to collect data from 218 medical institutions as of June 2021. In 2019, 82 medical institutions provided data, which showed that 2,184,666 patients received treatment at medical institutions. There were also 334,437 inpatients with at least one hospital stay and 2,011,628 outpatients with at least one visit. More than 200 laboratory test results were available. This database is a potential data source for producing descriptive studies, comparative effectiveness studies, studies of adverse effects, and prediction studies. The Real World Database provides an opportunity and strategy to produce real-world evidence for Japan.
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