Data Governance Arrangements for Real-World Evidence in Japan

In 2015, OHE Consulting published a report on data governance arrangements for real-world evidence (RWE) covering the specifics under which RWE was used in eight different countries: Australia, France, Germany, Italy, Sweden, the Netherlands, the UK and the US1. Two years later, Lilly commissioned a second report based on the South Korean setting, following the same method and structure as the original2. In 2015, OHE Consulting published a report on data governance arrangements for real-world evidence (RWE) covering the specifics under which RWE was used in eight different countries: Australia, France, Germany, Italy, Sweden, the Netherlands, the UK and the US1. Two years later, Lilly commissioned a second report based on the South Korean setting, following the same method and structure as the original2. This third report focuses on data governance arrangements for RWE in Japan. On this occasion, relevant information has been collected by the Japanese authors Hideo Yasunaga and Hayato Yamana through desk research, using the same pre-specified pro-forma as for the previous reports. 1 Cole,A., Garrison,L., Mestre-Ferrandiz,J., Towse,A., 2015. Data Governance Arrangements for Real-World Evidence.OHE Consulting Report, London: Office of Health Economics. 2 Lee,E.K., Park,J.A., Cole,A., Mestre-Ferrandiz,J., 2017. Data Governance Arrangements for Real-World Evidence in South Korea. OHE Consulting Report, London: Office of Health Economics.