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INTRODUCTION: The use of observational data to assess drug effectiveness and safety can provide relevant information, much of which may not be feasible to obtain through randomized clinical trials. Because observational studies provide critical drug safety and effectiveness information that influences drug policy and prescribing practices, transparent, consistent, and accurate reporting of these studies is critical. AREAS COVERED: We provide recommendations to extend existing reporting guidelines, covering the main components of primary research studies (methods, results, discussion). EXPERT OPINION: Our recommendations include extending drug safety and effectiveness guidelines to include explicit checklist items on: study registration, causal diagrams, rationale for measures of effect, comprehensive assessment of bias, comprehensive data cleaning steps, drug equivalents, subject-level drug data visualization, sex and gender-based analyses and results, patient-oriented outcomes, and patient involvement in research.

Original publication




Journal article


Expert opin drug saf

Publication Date





1 - 8


Drug effectiveness, drug safety, reporting checklist, reporting guidelines, reporting items, Bias, Checklist, Drug-Related Side Effects and Adverse Reactions, Guidelines as Topic, Humans, Observational Studies as Topic, Pharmaceutical Preparations, Research Design