2017 Volume 7 Issue 3 Pages 225-236
Real World Data (RWD) is an essential tool for pharmaceutical industry not only for commercial/marketing purposes but for unmet needs seeking, clinical trial designing (e. g., endpoint validation, patient segmentation) efficient country/site allocation and patient enrollment for clinical trials, patient safety surveillance, health-technology assessment and outcomes researches. Administrative datasets (e. g., claims) are primarily used because of their accessibility and size but EMR and patient registries can also be useful. In this summary article, current activities on RWD and perspective from the industry are illustrated. A questionnaire survey in 2015 suggested that around half of the companies already had an access to Japanese datasets. Indeed, many studies using Japanese datasets have already been published by industry researchers with and without collaboration with academic parties. Data Scientists in industry, regulatory authorities and academia shared their insights on clinical trial design using RWD at Data Science Round Table, especially on business cases for internal decision making. These examples are particularly valuable since they are not always published. RWD for safety studies are one of the hot topics since database studies will be an option of Post-Marketing Surveillance from FY2018. Nonetheless, it is still critical to note that any studies should be designed for purpose and one size does not fit all. National Database (NDB) covers almost entire population and can be a useful tool for epidemiology researches. Although industry does not have a direct access to NDB, several monthly summary tables are created on our request and will be published. The results will also be useful as a reference for external validation of commercially available datasets.
