{"title":"10 Practical Considerations for the Conduct of Multi-National/Database Studies in Pharmacoepidemiology.","authors":"Kenneth K C Man, Anton Pottegård","doi":"10.1002/pds.70203","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To share 10 practical considerations and common pitfalls in planning, executing, and reporting multi-national/database studies, with strategies to mitigate them.</p><p><strong>Approach: </strong>Practical guidance article synthesizing experience from multi-national/database projects and literature-based exemplars; no original data collection.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70203"},"PeriodicalIF":2.4000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12399347/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70203","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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