Benefit–risk assessment in a post‐market setting: a case study integrating real‐life experience into benefit–risk methodology
Pharmacoepidemiology and Drug Safety2014Vol. 23(9), pp. 974–983
Citations Over TimeTop 10% of 2014 papers
Christine E. Hallgreen, Hendrika A. van den Ham, Shahrul Mt‐Isa, Simon Ashworth, Richard Hermann, Steve Hobbiger, Davide Luciani, Alain Micaleff, Andrew Thomson, Nan Wang, Tjeerd van Staa, Gerald Downey, Ian Hirsch, Kimberley Hockley, Juhaeri Juhaeri, Marilyn Metcalf, Jeremiah Mwangi, Richard M. Nixon, Ruth Peters, Isabelle Stoeckert, Ed Waddingham, Ioanna Tzoulaki, Deborah Ashby, Lesley Wise
Abstract
The main challenges in applying formal methods for medical benefit-risk assessment for a marketed drug are related to outcome definitions and data availability. Data exist from many different sources (both randomised clinical trials and observational studies), and the variability in the studies is large.
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