title: State of the art in benefit-risk analysis: medicines.
abstract: Benefit-risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit-risk assessment takes place in multiple stages during a medicine's life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit-risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit-risk assessment in medicine is subject to debate and suffers from a number of limitations and is currently still under development. This state of the art review paper will discuss the various aspects and approaches to benefit-risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit-risk assessment a medicinal product will undergo during its lifecycle, from Phase I clinical trials to post-marketing surveillance and health technology assessment for inclusion in public formularies. The benefit-risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this review we conclude benefit-risk analysis in medicine is a developed practice that is subject to continuous improvement and modernisation. Improvement not only in methodology, but also in cooperation between organizations can improve benefit-risk assessment.
authors.affiliation: School of Nursing, University of Ulster, Shore Road, Newtownabbey (Jordanstown) BT37 0QB, United Kingdom. Luteijn-J@email.ulster.ac.uk
authors.forename: J M
authors.initials: JM
authors.lastname: Luteijn
authors.forename: B C
authors.initials: BC
authors.lastname: White
authors.forename: H
authors.initials: H
authors.lastname: Gunnlaugsdóttir
authors.forename: F
authors.initials: F
authors.lastname: Holm
authors.forename: N
authors.initials: N
authors.lastname: Kalogeras
authors.forename: O
authors.initials: O
authors.lastname: Leino
authors.forename: S H
authors.initials: SH
authors.lastname: Magnússon
authors.forename: G
authors.initials: G
authors.lastname: Odekerken
authors.forename: M V
authors.initials: MV
authors.lastname: Pohjola
authors.forename: M J
authors.initials: MJ
authors.lastname: Tijhuis
authors.forename: J T
authors.initials: JT
authors.lastname: Tuomisto
authors.forename: Ø
authors.initials: Ø
authors.lastname: Ueland
authors.forename: P A
authors.initials: PA
authors.lastname: McCarron
authors.forename: H
authors.initials: H
authors.lastname: Verhagen
mesh_terms: D055808:Drug Discovery; D005062:European Union; D004364:Pharmaceutical Preparations; D018570:Risk Assessment
chemical_list: D004364:Pharmaceutical Preparations