DINASTY in NSCLC - a multicenter retrospective study on real-world data using federated analysis

Real-world data is an important complement to randomized controlled trials and can be used to assess whether study results translate well to routine clinical practice and to groups of patients that are often excluded from clinical trials. The aim of this disease natural history and care quality assessment (DINASTY) study is to describe treatments, outcomes and care quality for patients with metastatic non-small cell lung cancer using real-world data. The study is a retrospective observational multicenter study conducted within DIGICORE, a non-profit European Economic Interest Grouping, formed to facilitate real-world evidence studies. The study will make use of methods developed within the network. Forty essential variables to describe patients with cancer, treatments and outcomes have been defined within DIGICORE and mapped to the Observational Medical Outcomes Partnership (OMOP) common data model (CDM). The study uses data that is drawn directly from the electronic patient health records at the patients local hospital and mapped to OMOP. Data are analyzed using a federated approach, meaning that patient-level data is analyzed locally, and only aggregated results are shared across centers and combined to present results for the full cohort. This method enables the delivery of multicenter studies and the presentation of results in a privacy-preserving way.