Background:
Robust evidence from large, randomized clinical trials has established the mortality reduction and overall clinical benefit of lung cancer screening (LCS) using low-dose computed tomography. As LCS transitions from controlled trials to real-world implementation, it is essential to reinforce these findings through the evaluation of real-world data (RWD). The Strengthening the Screening of Lung Cancer in Europe (SOLACE) consortium was established in part to address these needs. SOLACE supports the practical, large-scale implementation of equitable LCS across Europe. This multidisciplinary consortium unites 37 partners from 15 EU Member States, encompassing a wide range of specialties, amongst others, pulmonologists, radiologists, thoracic surgeons, general practitioners, health economists, medical physicists, clinical data scientists, public health experts, and patient advocates.

Objectives:
Within SOLACE, three pilot studies focused on increasing recruitment of previously underrepresented groups in LCS. These pilots focused on the enhanced engagement of women, hard-to-reach individuals (including socially deprived populations, ethnic minorities, and geographically remote communities), and individuals with co-morbidities linked to lung cancer risk (such as obstructive pulmonary diseases, interstitial lung abnormalities, and previous cancer diagnoses). To comprehensively assess both recruitment efficacy and the clinical performance of the screening programmes, SOLACE prioritized structured yet flexible data collection. This approach was designed to accommodate the heterogeneous RWD generated across the 19 data-providing sites while maintaining a level of harmonization that allows for meaningful cross-site analysis.

Methods:
Through extensive multidisciplinary collaboration, SOLACE developed a core common data model to capture key LCS findings and harmonize data across heterogeneous clinical and national environments. Both individualized participant-level and aggregated data are centrally collected within the SOLACE Database. These data span the entire LCS pathway, including demographic, recruitment and referral pathways, smoking history, screening outcomes, and radiation dose metrics. Where applicable, it also captures pulmonary nodule characteristics, follow-up management, diagnostic procedures, and treatment pathways.

Results:
The SOLACE Database contains 30,000 total participant records, including 22,000 individualized, participant-level records. The substantial proportion of individualized data provides a unique opportunity to perform detailed, multi-centric analyses across diverse European populations. Participants from previously underrepresented groups in LCS will comprise over 90% of the individualized dataset, allowing for robust subgroup-specific analysis to be performed.

Conclusion/Implications:
The SOLACE Database contains high-quality, multi-centric RWD that will enable the systematic evaluation of the benefits and potential risks of LCS. It will support the evaluation of recruitment methods, screening performance, and downstream clinical outcomes, as well as facilitate in-depth analysis within key sub-populations. This rich resource of real-world evidence will play a critical role in guiding the equitable implementation of LCS across Europe.