Norwegian version

Causality, complexity and evidence in pharmacovigilance

Detecting unknown adverse reactions of marketed medicines is challenging and needs improved methods to assess causality, as well as improved quality of clinical observations.

The approval of new medicines relies heavily on population trials. While responding to a public health utilitarian demand, it exposes single individuals to unpredicted and undetected effects.

Pharmacovigilance collects evidence of adverse reactions after the marketing of drugs to assist the best clinical choice for single patients. The field has been facing unsolved challenges, concerning how to evaluate, collect, confirm and communicate evidence.

Pharmacovigilance is largely based on real-life evidence, such as clinical observations and medical registries. It is difficult to assess causal relationships outside of a conventional study design.

The project uses novel interdisciplinary approach to renew the causal thinking in pharmacovigilance. We join pharmacology, theory of causality and clinical expertise to improve both methods and evidence base for causality assessment.

  • Participants

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  • Partners institutions

    • The Norwegian University of Life Science (NMBU)
    • The Norwegian Medicines Agency
    • Oslo University Hospital
    • The French Regional Centre for Pharmacovigilance, France
    • Drug Safety Research Unit, England