Our summary
In recent years, high-quality, patient-level, real-world clinico-genomic data has informed various aspects of healthcare, including drug development, optimizing study design, strengthening regulatory submission, and delivering real-time insights that influence clinical decisions. However, it is critical that the data be representative of the target population as it impacts the generalizability of the results researchers can draw from analyses based on the data.
The Flatiron Health-Foundation Medicine Clinico-Genomic Databases (CGDBs) are a set of real-world data sources that link comprehensive genomic profiling (CGP) data with electronic health records for people with cancer.
To assess the representativeness of the CGDBs, researchers from Flatiron Health and Foundation Medicine compared the demographic and clinical characteristics of patients in the CGDBs with the Flatiron Health Research Databases (FHRDs) and The National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) population-based cancer registry.
Why this matters
This comparative analysis of real-world US-based oncology databases provides valuable insights into the similarities and differences in patient characteristics across the three data sources. These insights will help researchers and regulators better contextualize evidence from the CGDBs, which is especially beneficial as the adoption of CGP in routine clinical practice increases.