A structured pharmacoepidemiology roadmap guides early-career researchers in study designNew roadmap helps researchers study drug safety

Pharmacoepidemiology is an evolving discipline at the intersection of pharmacology, epidemiology, and clinical medicine, playing a pivotal role in evaluating real-world medication use, safety, and effectiveness. This review aims to provide early-career researchers with a structured and practical roadmap to navigate the field. The manuscript is organized around a step-by-step research framework, guiding readers from formulating a clear research question and protocol development, through study design selection and identification of appropriate data sources, to the operationalisation of key variables, including exposures, outcomes, and covariates. It further addresses statistical analysis and modelling, followed by critical evaluation of biases and limitations, and concludes with reporting and interpretation of findings. This integrated structure reflects the real-world progression of pharmacoepidemiologic research and supports coherent study planning and execution. Recent advancements in the field include the increasing use of real-world data, causal inference approaches, and advanced analytical methods, supported by large healthcare databases and evolving data infrastructures. In addition, the adoption of reporting standards such as STROBE and RECORD has improved transparency, reproducibility, and methodological rigor. This review provides an integrated, workflow-oriented perspective that bridges methodological concepts with practical application, equipping early-career researchers to design robust studies and contribute meaningfully to evidence-based drug safety and effectiveness research.