ReviewClinical pharmacology and therapeutics2020
Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model.
Review in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Renoprotective effect of SGLT-2 inhibitors among type 2 diabetes patients with different baseline kidney function: a multi-center study.Cardiovascular diabetology · 2021Pooled it
- A systematic review of how missing data are handled and reported in multi-database pharmacoepidemiologic studies.Pharmacoepidemiology and drug safety · 2021Pooled it
- Sex-stratified disproportionality signals of adverse events with allopurinol and febuxostat: a retrospective pharmacovigilance analysis of FAERS and EudraVigilance.Clinical rheumatology · 2026Article
- Article
- Implementation of OMOP and ConcePTION Common Data Models in CPRD GOLD: Risk of Bleeding and Cardiovascular Outcomes From Anticoagulant Use.Clinical pharmacology and therapeutics · 2026Article
- An operational target trial emulation framework for causal inference using electronic health record data.NPJ digital medicine · 2026Review
- Comorbidities, medication use, and overall survival in eight cancers: a multinational cohort study of 1.7 million patients across Europe.The Lancet regional health. Europe · 2026Article
- Unifying to Advance Understanding: Collaborative, Community-Driven and 'Open' Approaches for Better Science in Sport.Sports medicine (Auckland, N.Z.) · 2026Review
- Performance of the Self-Controlled Case Series for Drug Safety Signal Detection: A Multi-Database Study.Pharmacoepidemiology and drug safety · 2026Article
- Review
- Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies.Therapeutic innovation & regulatory science · 2025Article
- Strengthening Pharmacoepidemiology in a Changing Research Environment: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).Pharmacoepidemiology and drug safety · 2025Review
- Trajectories of Adherence to Biologics in Patients With Inflammatory Bowel Diseases: A Large-Scale Multi-Regional Italian Study Through the VALORE Distributed Database.Pharmacoepidemiology and drug safety · 2025Article
- Hypertension, Diabetes and Depression as Modifiable Risk Factors for Dementia: A Common Data Model Approach in a Population-Based Cohort, with Study Protocol and Preliminary Results.Journal of clinical medicine · 2025Article
- 10 Practical Considerations for the Conduct of Multi-National/Database Studies in Pharmacoepidemiology.Pharmacoepidemiology and drug safety · 2025Review
- Core Concepts in Pharmacoepidemiology: Multi-Database Distributed Data Networks.Pharmacoepidemiology and drug safety · 2025Review
- Federated learning: a privacy-preserving approach to data-centric regulatory cooperation.Frontiers in drug safety and regulation · 2025Article
- Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information.Frontiers in drug safety and regulation · 2025Article
- Real-World Evidence BRIDGE: A Tool to Connect Protocol With Code Programming.Pharmacoepidemiology and drug safety · 2024Article
- Adaptation of risk prediction equations for cardiovascular outcomes among patients with type 2 diabetes in real-world settings: a cross-institutional study using common data model approach.Cardiovascular diabetology · 2024Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Although postmarketing studies conducted in population-based databases often contain information on patients in the order of millions, they can still be underpowered if outcomes or exposure of interest is rare, or the interest is in subgroup effects. Combining several databases might provide the statistical power needed. A multi-database study (MDS) uses at least two healthcare databases, which are not linked with each other at an individual person level, with analyses carried out in parallel across each database applying a common study protocol. Although many MDSs have been performed in Europe in the past 10 years, there is a lack of clarity on the peculiarities and implications of the existing strategies to conduct them. In this review, we identify four strategies to execute MDSs, classified according to specific choices in the execution: (A) local analyses, where data are extracted and analyzed locally, with programs developed by each site; (B) sharing of raw data, where raw data are locally extracted and transferred without analysis to a central partner, where all the data are pooled and analyzed; (C) use of a common data model with study-specific data, where study-specific data are locally extracted, loaded into a common data model, and processed locally with centrally developed programs; and (D) use of general common data model, where all local data are extracted and loaded into a common data model, prior to and independent of any study protocol, and protocols are incorporated in centrally developed programs that run locally. We illustrate differences between strategies and analyze potential implications.
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