Evaluating the Readiness of Saudi Oncology Real-World Data for Standardization and Quality Enhancement

Real-world data (RWD) are increasingly used in oncology research, regulatory decisions, and clinical practice; however, variability in data quality and lack of standardization remain major limitations. This study assessed the readiness of oncology RWD from Saudi health care centers for standardization and evaluated their completeness and accuracy.

Deidentified electronic health records for adult patients (18 years and older) diagnosed with breast cancer, thyroid cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, or renal cell carcinoma were extracted from five health care centers within the Saudi Real-World Evidence Network. Readiness for standardization was evaluated by assessing alignment with data elements in the Minimal Common Oncology Data Elements (mCODE) framework, a standardized and clinically focused oncology data model. Data quality was evaluated using two dimensions: completeness, defined as the proportion of patients with at least one entered value for each element; and accuracy, defined as the proportion of correct entries based on verification checks (including plausibility and consistency). Outcomes were calculated at the element level and weighted to generate domain- and center-level proportions.

A total of 20,671 oncology patients were included. Overall weighted alignment with mCODE domains was moderate (62.43%). The patient domain showed the highest alignment (71.43%), whereas the outcome domain exhibited significant gaps. Data completeness was low to moderate (49.02%), with higher levels in common cancers (54.33%) than in rare cancers (51.50%). Data accuracy was high overall (95.03%), with rare cancers showing higher accuracy (98.76%) than common cancers (94.62%).

Saudi oncology RWD show moderate alignment with mCODE, with consistently high accuracy across domains. However, gaps in data completeness highlight the need for broader adoption of standardized data frameworks to support interoperability and enable nationwide research and regulatory use.