Presentation (CTI)

OBJECTIVES: Two recent real-world data (RWD) frameworks provide much-needed guidance around data quality expectations for submission of real-world evidence (RWE) to global health authorities. Comparison of the FDA Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) and EMA Data Quality Framework (DQF) is important for identifying potential areas of harmonization, supporting more robust use of RWD in global regulatory submissions.
METHODS: An in-depth review of the FDA QCARD and EMA DQF was conducted to compare their approaches to assessing the quality and fitness-for-purpose of RWD for regulatory decision-making.
RESULTS: The EMA DQF applies to all RWD used in medicines regulation and evaluates data across key dimensions, such as reliability, extensiveness, coherence, and relevance. Its assessment process includes general quality assurance, a high-level relevance assessment, and a detailed fitness-for-use evaluation. In contrast, the FDA QCARD is oncology-specific and focuses on early RWD study proposals. It outlines minimum data and study design elements—including data source characteristics, temporality, population, exposure, comparators, endpoints, statistical plan, and data quality assurance—with the purpose of facilitating efficient review and communication between sponsors and FDA reviewers. Key areas of harmonization between FDA QCARD and EMA DQF include establishing common definitions and metrics for data quality dimensions such as reliability, relevance, and completeness; aligning minimum data and study design elements required for regulatory submissions; and standardizing processes for assessing the fitness-for-purpose of RWD.
CONCLUSIONS: Both frameworks provide meaningful approaches for evaluating the quality and fitness-for-purpose of RWD, despite differences in their scope and operationalization. While each offers valuable guidance, further harmonization—particularly regarding templates, minimum data elements, and quality dimensions/assessments—may help streamline the use of RWD in global regulatory submissions. By aligning on these aspects, both agencies can promote greater consistency, transparency, and efficiency in the regulatory review of RWD/E, ultimately supporting more robust global regulatory decision-making.