Overview
In oncology, electronic health records (EHR) play a pivotal role in generating real-world evidence (RWE) to guide clinical decisions and policy. However, challenges persist in ensuring the clinical depth, consistency, and country-level comparability of such datasets, particularly for multinational studies including Europe and Asia. For regulatory purposes and health technology assessment (HTA), the necessary local data are often sparse or unavailable.
Diverse teams of Flatiron Health researchers, software engineers, and medical oncologists local to each geography developed oncology EHR-derived real-world data (RWD) datasets in the UK, Germany, and Japan. This paper details how teams established the provenance, governance, de-identification and anonymization processes, and analytic trusted research environment necessary to achieve this, adhering to the ISPOR EHR-Derived Data Suitability Checklist, and ensuring the trustworthiness, reliability, and relevance of these datasets. Flatiron Health Research Database is now expanded to include RWD from the UK, Germany, and Japan with common data models for harmonized pooling with US Flatiron data to support rigorous multinational RWE studies.
Why this matters
The methods and approach described in this paper enable global researchers with the tools to investigate treatment patterns and outcomes across diverse healthcare systems, fostering high-quality, multinational evidence generation—all while working within local regulatory requirements. This work has the potential to accelerate the development of therapies, improve treatment strategies, and most importantly, benefit patients worldwide by ensuring that high-quality RWE informs clinical decisions and health policies on a global scale.