Pharmacovigilance as Personalized Evidence

Francesco DE PRETIS, William PEDEN, Jürgen LANDES, Barbara OSIMANI*

*Corresponding author for this work

Research output: Book Chapters | Papers in Conference ProceedingsBook ChapterResearchpeer-review


Personalized medicine relies on two points: 1) causal knowledge about the possible effects of X in a given statistical population; 2) assignment of the given individual to a suitable reference class. Regarding point 1, standard approaches to causal inference are generally considered to be characterized by a trade-off between how confidently one can establish causality in any given study (internal validity) and extrapolating such knowledge to specific target groups (external validity). Regarding point 2, it is uncertain which reference class leads to the most reliable inferences.
Instead, pharmacovigilance focuses on both elements of the individual prediction at the same time, that is, the establishment of the possible causal link between a given drug and an observed adverse event, and the identification of possible subgroups, where such links may arise. We develop an epistemic framework that exploits the joint contribution of different dimensions of evidence and allows one to deal with the reference class problem not only by relying on statistical data about covariances, but also by drawing on causal knowledge. That is, the probability that a given individual will face a given side effect, will probabilistically depend on his characteristics and the plausible causal models in which such features become relevant. The evaluation of the causal models is grounded on the available evidence and theory.
Original languageEnglish
Title of host publicationPersonalized Medicine in the Making: Philosophical Perspectives from Biology to Healthcare
PublisherSpringer, Cham
Number of pages25
ISBN (Electronic)9783030748043
ISBN (Print)9783030748036
Publication statusPublished - 2022
Externally publishedYes

Publication series

NameHuman Perspectives in Health Sciences and Technology
PublisherSpringer Cham
ISSN (Print)2661-8915
ISSN (Electronic)2661-8923

Bibliographical note

Francesco De Pretis, Barbara Osimani and William Peden acknowledge funding from the European Research Council (PhilPharm—GA n. 639276) and the Marche Polytechnic University (Ancona, Italy). Jürgen Landes gratefully acknowledges funding from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)—432308570 and 405961989.


  • Drug safety
  • Personalized medicine
  • Pharmacosurveillance
  • Pharmacovigilance
  • Precision medicine


Dive into the research topics of 'Pharmacovigilance as Personalized Evidence'. Together they form a unique fingerprint.

Cite this