Real World Data in Japan: Chapter I NDB

Abstract

Real world data plays an important role in rheumatology, allowing us to gain deeper insights into disease progression and treatment outcomes, including safety. It takes us beyond the conclusions of a clinical trial and allows us to “test” outcomes in an uncontrolled, real-life environment. However, in order to generate trustworthy conclusions it is important that the provenance of and methodological considerations for handling real-world data are considered. This is increasingly true in this new era of big data, where not only the methods of handing such large datasets are critical, but also the ethics surrounding their collection and use. This overview summarises the key role real-world data has played in rheumatology, highlights key methodological challenges in analysing real-world data, and presents challenges for the future in order to continue to generate reliable scientific output using real-world data.