Causality assessment in pharmacovigilance: principles and fundamentals of causal inference

Abstract

Causality (or causal inference) has been a topic of intense debate among philosophers, epidemiologists, statisticians, and other clinical scientists. In pharmacovigilance, as in many other situations, there is not just one possible cause for an effect, but several. Causality imputation aims, through its own methodologies, to assess the nature of the relationship between a suspected adverse reaction and a particular drug or health product, seeking to establish the existence (or absence) and robustness of a causal link. This article focuses on a reflection on the importance of applying the principles and fundamentals of causal inference to pharmacovigilance, fundamental to the scientific rigor of an area governed by the difficulty of controlling for the unknown.