Session (CTI)

PURPOSE: The quality, integrity, and methodological rigor of real-world data (RWD) are essential for generating real-world evidence (RWE) to support health technology assessment (HTA). Data sources such as electronic medical records, claims databases, health surveys, and patient registries provide valuable insights for healthcare stakeholders. However, regional disparities in RWD implementation can weaken outcome reliability and impede the transfer of evidence across regions. This workshop examines evolving paradigms, applications and challenges of RWD in China, Japan, and Australia. By offering regional insights, it aims to optimize RWD integration into HTA frameworks and provide global perspectives to support evidence-based decision-making.

DESCRIPTION: Attendees will gain an understanding of RWD use in HTA, with emphasis on data quality, integration, and regional practices. The session includes: a) the generation, quality, and accessibility of RWD in China, Japan, and Australia, and its role in healthcare decision-making; b) methodological approaches to ensure RWE meets HTA evidence standards; c) case studies on how RWD informs market access and reimbursement. Prof. Gordon G. Liu will chair the session, introducing the RWD-driven HTA landscape (10 min). Prof. Jing Wu will discuss RWD and RWE use in China, focusing on data quality and HTA applications (12 min). Prof. Isao Kamae will share the current status, challenges, and opportunities for RWD and RWE in Japan (12 min). Dr. Feili Zhao will present how RWD supports product development, evidence generation, and market access in Australia from the industry perspective (12 min). A 14-minute audience interaction will feature structured discussion and problem-solving based on an RWD-driven HTA scenario. The session will offer key insights into regional RWD ecosystems and inform evidence-based HTA decision-making.