Corpus ID: 11911042

Assessing the benefit:risk ratio of a drug - randomized and naturalistic evidence

@article{Curtin2011AssessingTB,
  title={Assessing the benefit:risk ratio of a drug - randomized and naturalistic evidence},
  author={François Curtin and Pierre Schulz},
  journal={Dialogues in Clinical Neuroscience},
  year={2011},
  volume={13},
  pages={183 - 190}
}
  • François Curtin, Pierre Schulz
  • Published 2011
  • Medicine
  • Dialogues in Clinical Neuroscience
  • Randomized evidence from clinical trials and naturalistic evidence collected from pharmacoepidemiology and pharmacovigilance activities both contribute to the initial and continuous assessment of the benefits and risks of a drug, ie, the balance between therapeutic efficacy and safety risks. Benefit-risk assessment (BRA) mainly relies on a qualitative assessment of quantitative data. Current attempts to quantify BRA are reviewed and discussed, along with the expectations of regulatory… CONTINUE READING

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