Innovative Approaches in Pharmacovigilance: Enhancing Detection and Analysis of Adverse Drug Reactions in Clinical and Real-World Settings

This Research Topic aims to highlight novel methodologies and applications in pharmacovigilance that improve the detection, monitoring, and understanding of adverse drug reactions. By fostering interdisciplinary research that integrates large-scale databases with clinical observations, this collection seeks to accelerate the translation of pharmacovigilance insights into effective risk management strategies.

Pharmacovigilance plays a critical role in identifying and mitigating the risks of adverse drug reactions throughout a drug’s lifecycle. Traditional methods, while effective, often face challenges such as delayed signal detection and limited real-world applicability. Studies involving FAERS data mining, real-world safety assessments of cancer drugs, and novel tools in intensive care settings demonstrate the expanding landscape of pharmacovigilance research. These innovations are essential to safeguarding public health in increasingly complex therapeutic environments.



We invite original research articles, reviews, and case studies focusing on innovative pharmacovigilance approaches, including but not limited to:

- Signal detection and mining from large-scale adverse event reporting systems (e.g., FAERS, FDA databases, VigiBase, EudraVigilance, and national pharmacovigilance databases).

- Real-world evidence studies assessing drug safety in diverse patient populations.

- Application of novel methodologies, such as global trigger tools, in clinical settings.

- Comparative pharmacovigilance studies of specific drug classes or therapeutic areas.

- Studies addressing challenges in pharmacovigilance in emerging therapeutic contexts.

Please note: Isolated data mining studies using disproportionality analyses of databases containing spontaneously reported adverse events, frequently lead to misinterpretation due to various reporting biases, lack of structured control, and insufficient demographic details. Presenting such analyses in isolation typically does not yield clinically actionable safety findings without the broader context of a comprehensive signal evaluation. To ensure rigor and relevance, all submissions to the journal must be complemented by a proper systematic review and/or thorough analyses of reported cases, and adhere to the READUS-PV guidelines (The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance). Authors are expected to ensure compliance with the corresponding checklist before proceeding with submission to the journal. Full publication of the READUS-PV guidelines is available: https://pmc.ncbi.nlm.nih.gov/articles/PMC11116242/pdf/40264_2024_Article_1421.pdf