Presentation (CTI)

OBJECTIVES: Public-interest real-world data (RWD) research is often evaluated by publications, methodological rigor, and data completeness. However, these metrics don't necessarily reflect its value for pharmaceutical decision-making. We propose a paradigm shift: assessing the value of public-interest RWD research by the breadth of strategic decisions its evidence can support. Using Japan's National Database of Health Insurance Claims and Specific Health Checkups (NDB) as a case study, we developed a conceptual framework linking public-interest evidence generation to pharmaceutical strategy.
METHODS: The framework was developed based on pharmaceutical management processes and NDB characteristics. The NDB captures virtually all reimbursed healthcare services under Japan's universal health insurance system, providing nationwide information on disease epidemiology, treatment patterns, healthcare resource utilization, and regional variation. Strategic management activities were decomposed into key decision domains, and public-interest RWD evidence was qualitatively assessed. The framework also incorporates a value-of-information perspective, whereby additional data sources should be acquired only when their incremental decision value exceeds acquisition cost.
RESULTS: Ten evidence domains were identified: disease landscape assessment, unmet needs quantification, market opportunity assessment, patient journey analysis, competitive landscape assessment, regional practice variation analysis, guideline adherence assessment, real-world effectiveness evaluation, pharmacovigilance signal detection, and future scenario simulation. These domains support strategic decision-making across research and development, medical affairs, market access, and lifecycle management. The framework positions nationwide claims databases such as the NDB as strategic evidence infrastructures, not merely research resources, for broad management decisions at relatively low data acquisition cost.
CONCLUSIONS: The value of public-interest RWD research should be assessed not by the quantity of data collected or the number of publications produced, but by the extent to which the resulting evidence supports strategic decision-making. This framework redefines the role of nationwide claims databases from research assets to strategic evidence infrastructures and provides a new perspective for evaluating investments in RWD generation and utilization.