OBJECTIVES: I-O Optimise, a pan-European initiative aimed at developing a multinational research framework, leverages existing real-world data sources (RWDS) to provide ongoing timely insights into the evolving lung cancer landscape. The goal, ultimately, is to improve outcomes for lung cancer patients. As RWDS’ structure, content and scope vary, database-mapping has been undertaken to explore RWDS’ suitability for addressing specific research questions.

METHODS: RWDS were identified via literature searches, interviews with researchers and I-O Optimise affiliates and review of existing QuintilesIMS initiatives. RWDS were shortlisted based on population representativeness, disease coverage (non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC] and mesothelioma), data quality/completeness, source type, estimated size and other attributes. Final selection was based on: pan-European coverage, research goal alignment and timely data availability.

RESULTS: In addition to SCAN-LEAF (pre-identified Scandinavian RWDS), 490 RWDS were identified with 124 (25.3%) shortlisted. Of the shortlisted, 15 (12.1%) are under appraisal, 91 (73.4%) have completed appraisal, 4 (3.2%) are under assessment and 14 (11.3%) are fully assessed. Of the assessed RWDS, 7 (50.0%) have progressed to a comprehensive appraisal of research goal alignment and capacity (Germany, Italy, Netherlands, Portugal and UK); All 7 address clinical outcomes and treatment/practice patterns, 6/7 address pharmacovigilance, 5/7 address healthcare resource utilization and 1/7 addresses patient-reported outcomes. These 7 RWDS plus SCAN-LEAF will provide ~395,000 NSCLC, SCLC and mesothelioma cases.

CONCLUSIONS: A structured assessment of RWDS facilitated development of a flexible collaborative research framework. The challenges of conducting such initiatives were also revealed, as most available RWDS proved unsuitable. Drawing together diverse RWDS enables examination of a wide range of research questions, reflects the diversity of real-world clinical practice and provides standardisation that allows insights to be drawn across data sources. I-O Optimise has the potential to elucidate real-world management of lung cancer in Europe, complementing ongoing clinical trial-based research.