Overview
As healthcare authorities and European Joint Clinical Assessment (JCA) bodies increasingly consider real-world evidence (RWE) transported across international borders, structured approaches are needed to review and compare cross-country research. Researchers from the Flatiron FORUM research consortium and academic partners synthesized published literature and international survival studies to develop a practical guide for evidence evaluation and synthesis.
The study identified five key methodological dimensions that influence interpretation of transportability: data source fit-for-purpose (e.g., electronic health records vs. national registries), availability of individual versus aggregate-level data, comparability of patient characteristics and treatment patterns, data completeness and event timing (such as missing variables and follow-up duration), and feasibility and sample size constraints in smaller countries or rare cancer populations.
Why this matters
This framework provides a structured approach for assessing when RWE generated in one country may be informative in another. By defining clear evaluation criteria around data quality, population comparability, and analytic feasibility, these recommendations may support greater consistency and transparency in international RWE assessment, and help inform health technology assessment and regulatory decision making.