Current and Future Opportunities for the Use of Real World Data in the Asia Pacific Region

We sought to gain a greater understanding of the current Real-World-Data (RWD) landscape in the Asia-Pacific region, and the potential barriers that may shape or limit RWD access. This landscape analysis included information on 8 major Asia-Pacific countries: Australia, China, Hong Kong, Japan, New Zealand, Singapore, South Korea and Taiwan. Therapeutic fields-of-focus included respiratory diseases, infectious disease, chronic kidney disease, immune-mediated inflammatory disease and oncology. Literature review was undertaken to collate RWD sources currently available in each country, complemented with in-depth interviews with local data experts to gain further insight on trends in the availability of high-quality RWD and navigation around access challenges. 268 data sources of 11 types were assessed as high-quality across Asia (based on legislation/technological capabilities of the data infrastructure, the extent to which RWD was embedded into decision making, and type of decision it informs). The main barriers to leverage of RWD in Asia include: legal and patient-privacy restrictions to observational data analysis (pharma-sponsored studies especially are regulated in many Asian countries, and direct-access to government/academic databases is controlled), lack of harmonization/mapping to a common data model between repositories (different data structures and variable collection in different hospitals/administrative sources), and fragmented data sources (inaccuracies/duplicates in available datasets). Several governmental initiatives are expected address these issues, with strong focus on the development of integrated eHealth infrastructure more broadly - except for Japan where the linkage options are less developed, as concerns regarding privacy and protection of data are paramount. Despite the challenges in leveraging RWD in Asia, initiatives are growing to bring new, multi-stakeholder approaches to accelerate cross-platform harmonization, digitalization and analytics along with open access. These innovations will bring solutions to different stages of drug development lifecycle, provide verifiable evidence for payers and ultimately better health outcomes for patients. Funding: GSK (PRJ3061)