Presentation (CTI)

OBJECTIVES: This study assesses access to Real-World Data (RWD) in Asia and compares it with the United States (US) and Europe. The objective is to summarize what is known about access, identify gaps, and, where relevant, explain why some available RWD may not be accessible to certain parties or at certain times—often due to ethical considerations or strict data-sharing controls.
METHODS: We reviewed RWD studies in Asia published from January 1, 2020 to July 4, 2025 in the MEDLINE database. We conducted targeted interviews with 12 data vendors active in the RWD space to deepen our understanding of the current landscape of RWD access for selected countries (China, Japan, US, UK, Germany, France). We mapped available databases to their access models (direct or indirect) and summarized the operational, analytical, and governance implications.
RESULTS: Our systematic search identified 3,213 records. The predominant data sources were registries (50.8%), followed by claims for (36.4%), EMR for (4.7%) and other sources for (8.1%). Our qualitative analysis revealed that across China, Japan, the US, and Europe, RWD accessibility varies by access model. Direct access is common in the US and Europe, Japan uses both direct and indirect access, and China largely relies on protocol-based applications with third-party access. Direct access enables use of raw data through integration with internal/external tools, regular refreshes, interoperable data models, and enables regular and exploratory analyses. In contrast, indirect access withholds raw data, requires predefined protocols, limits analytic flexibility and often ends up with longer time to obtain results.
CONCLUSIONS: Comparing China and Japan with the US and Europe highlights distinct RWD access models and current practice, helping industry stakeholders and policymakers choose governance approaches that support RWD use in the global public interest.