Overview
This study explores two critical assessments of real-world data (RWD) quality in regulatory submissions: the FDA Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) and the EMA Real-World Data Quality Framework (RW-DQF). This study aimed to provide a detailed comparison to identify opportunities for sponsors to streamline high-quality submissions of RWD/E to both regulators, which could enhance the global use of RWD in regulatory contexts.
The FDA QCARD and EMA RW-DQF are pivotal in ensuring RWD's relevance and reliability for regulatory purposes. The FDA QCARD, with its oncology-specific focus, emphasizes early study proposals and outlines essential data and design elements. Meanwhile, the EMA RW-DQF applies broadly across all therapeutic areas, offering a comprehensive assessment of data quality dimensions.
Why this matters
The researchers found that both documents provide meaningful approaches for assessing the quality of real-world data, with a focus on fit-for-purpose data through demonstrating relevance and reliability. A detailed fit-for-purpose assessment of a real-world data source, related to a specific research question, and focused on data accuracy, completeness, availability, generalizability, etc, can be conducted for both FDA and EMA submissions of RWE. This alignment can streamline regulatory reviews, promoting more efficient and robust global decision-making. Ultimately, both the QCARD and RW-DQF support the broader adoption of RWD, enhancing the ability to make informed regulatory decisions worldwide.