Real-world data (RWD) and real-world evidence (RWE) can improve patient outcomes by optimizing clinical trials and accelerating specific treatments. They are also growing in importance for regulatory evaluations and commercial decisions. Nevertheless, stewardship of RWD poses challenges, such as ensuring data quality and its fit for purpose. Evaluating data quality involves assessing completeness, plausibility, traceability, and interoperability. Data stewards must validate processes for completeness and accuracy, assess data credibility, trace study results to original data sources, and adopt models fostering data interoperability. Establishing that the data is fit for purpose involves verifying it answers the end user’s questions and meets quality rules. As the role of RWD and RWE evolves, data stewardship best practices are vital for ensuring data quality.
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[Source: Health Data Management, November 6th, 2023]