ArticleBMC cancer2026
Real-world evidence from Germany: representativeness analysis and mortality endpoint validation in electronic health record-derived oncology cohorts.
Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundHigh-quality real-world data (RWD) for oncology research remains limited in Germany despite significant clinical need. Electronic health record (EHR)-derived datasets offer potential to capture longitudinal clinical information, but their value depends on representativeness and data quality. We characterized EHR-derived oncology cohorts from Germany, evaluating alignment with national benchmarks and validating mortality endpoints for real-world evidence generation.
methodsWe analyzed deidentified EHR data from the Germany Flatiron Health Research Database comprising adult patients diagnosed with breast cancer, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) between 2016 and 2024. Demographic and clinical characteristics were compared to national benchmarks. Overall survival was estimated using Kaplan-Meier methods. We validated our composite mortality variable against German Cancer Registry data.
resultsThe breast cancer cohort (n = 1,305, median age 58 years) included 75% early-stage disease, 80% invasive ductal carcinoma, 67% HR+/HER2-, and 19% triple-negative cases. The NSCLC cohort (n = 866, median age 69 years) comprised 49% stage IV disease, 73% non-squamous histology, and 16% EGFR-positive tumors among tested patients. The CRC cohort (n = 774, median age 67 years) included 31% stage IV disease with 90% receiving primary surgery. Cohort characteristics closely aligned with national benchmarks. Median overall survival from first-line therapy was 26.0 months (breast), 13.4 months (NSCLC), and 21.5 months (CRC). Mortality validation demonstrated 87.7% sensitivity and 91.7% specificity for vital status classification, with 98.8% temporal accuracy within 30 days.
conclusionsGerman EHR-derived cancer cohorts are representative of national populations with validated mortality endpoints, supporting their use for robust real-world evidence generation in oncology research.
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