Man, Kenneth; Pottegård, Anton; (2025) 10 Practical Considerations for the Conduct of Multi-National/Database Studies in Pharmacoepidemiology. Pharmacoepidemiology and Drug Safety , 34 (9) , Article e70203. 10.1002/pds.70203.

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Abstract

Background: Multi-national/database pharmacoepidemiological studies are increasingly used to address questions that require pooled evidence across populations but introduce challenges in design, harmonization, and analysis. Objective: To share 10 practical considerations and common pitfalls in planning, executing, and reporting multi-national/database studies, with strategies to mitigate them. Approach: Practical guidance article synthesizing experience from multi-national/database projects and literature-based exemplars; no original data collection. Results: We summarize ten considerations spanning: protocol development; follow-up time and eligibility assessment; data harmonization (including thorough metadata and master mapping tables); feasibility checks within each source; statistical model diagnostics; and transparent reporting. We illustrate how local clinical practices, coding systems, and reimbursement policies can shape outcomes and interpretation, and we emphasize the need for proactive, consistent communication among collaborators to ensure aligned implementation. Conclusion: Multi-national/database studies are complex but feasible with structured planning, clear communication, and proactive problem-solving. Adopting the outlined practices can reduce avoidable heterogeneity and improve the robustness and interpretability of findings.

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