Characteristics of Real-World Data (RWD) in Spain: A Systematic Review

OBJECTIVES: Spain is the fifth most populated country in the European Union, with 47 million people and 99.0% covered through health insurance. With the increasing application of real-world data in regulatory decision-making, this study aims to summarize the real-world data landscape within Spain using a systematic literature review of real-world database studies.

METHODS: An electronic search was performed in PubMed in Feb 2024 to identify studies utilizing ≥ 1 RWD published between Jan 2019 and Feb 2024. We included RWDs as a byproduct of the healthcare system (claims, electronic medical records, EMRs) and purpose-driven (registries, surveillance, surveys, app) or linkage of different RWDs.

RESULTS: Of 334 retrieved citations, 174 studies included ≥1 RWD. EMRs were the most commonly utilized type of RWD source. Most EMRs were specific to Spanish regions, given that health insurance is administered through 17 autonomous regions within Spain. Valencia, Galicia, Aragon, Madrid, Catalonia, Castilla-La Mancha, and Navarra were common regional EMRs. SIDIAP, BIFAP, BIG-PAC, IQVIA's clinical practice RWD, National Hospitalization Databases, and Spanish Ministry of Health database were most frequently utilized in multi-regional EMRs. In addition, sixteen registry databases were identified with covered disease areas, including COVID-19, cancer, and rare diseases. Two surveillance-based databases were the Spanish National Study of Adverse Events in Primary Care and the Andalusian Epidemiological Surveillance System. Twelve studies utilized Adelphi disease-specific program-based data consisting of chart-review-based data on clinical characteristics, treatment, and outcomes reported by participating physicians as cross-sectional snapshots. Four studies utilized consortium or drug surveillance-based databases. Most databases had a latency period of 3 month to a year. Accessibility and conversation of existing RWDs to common data models were limited.

CONCLUSIONS: Our is an up to SLR on the RWD landscape in Spain. Findings showed RWDs were mostly EMRs, and fragmented across regions with potential accessibility issues.