Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety

Tarek A. Hammad () and Simon Davies
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Tarek A. Hammad: Takeda Development Center Americas, Inc.
Simon Davies: Takeda Development Center Americas, Inc.

Drug Safety, 2025, vol. 48, issue 6, No 1, 587-593

Abstract: Abstract Decision making in drug safety is a complex and iterative process that requires the integration of diverse evidence sources, scientific reasoning, and clinical judgment. Diverging opinions among stakeholders—including pharmacovigilance professionals, regulatory authorities, clinical researchers, statisticians, and epidemiologists—often stem from differences in data interpretation, methodological approaches, and thresholds for concern or action. This paper examines the key sources of these divergences and presents a structured framework to enhance alignment in drug safety decision making. The proposed framework outlines three core dimensions: evidence assessment, interpretation, and action. It distinguishes between quantitative aspects, such as effect magnitude and measurement error, and qualitative considerations, including contextual interpretation and risk thresholds. The framework also underscores the importance of multidisciplinary collaboration, as safety professionals must actively engage with other scientific and regulatory stakeholders to ensure a comprehensive evaluation of the evidence. A fundamental challenge in pharmacovigilance is the need to communicate the complexities of drug safety assessment to a broader audience, including those who may not be familiar with the nuances of safety decision making. This paper aims to serve not only as a resource for new pharmacovigilance professionals, but also as a tool to facilitate clearer communication between disciplines. By adopting a structured approach and fostering open dialogue, drug safety professionals can enhance transparency and improve regulatory and clinical decision-making processes.

Date: 2025
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DOI: 10.1007/s40264-025-01537-6

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