Balancing benefit and risk of medicines: a systematic review and classification of available methodologies
Pharmacoepidemiology and Drug Safety2014Vol. 23(7), pp. 667–678
Citations Over TimeTop 1% of 2014 papers
Shahrul Mt‐Isa, Christine E. Hallgreen, Nan Wang, Torbjörn Callréus, Georgy Genov, Ian Hirsch, Stephen F. Hobbiger, Kimberley Hockley, Davide Luciani, Lawrence D. Phillips, George Quartey, Sinan B. Sarac, Isabelle Stoeckert, Ioanna Tzoulaki, Alain Micaleff, Deborah Ashby, On behalf of the IMI‐PROTECT benefit–risk participants
Abstract
Methodologies to help benefit-risk assessments of medicines are diverse and each is associated with different limitations and strengths. There is not a 'one-size-fits-all' method, and a combination of methods may be needed for each benefit-risk assessment. The taxonomy introduced herein may guide choice of adequate methodologies. Finally, we recommend 13 of 49 methodologies for further appraisal for use in the real-life benefit-risk assessment of medicines.
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