title: A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis.
abstract: OBJECTIVE
  One of the most important uses of benefit-risk assessment pertains to approval of new medicines by regulatory authorities and the subsequent review of these products during their life-cycle when new safety and/or efficacy data becomes available. At present, there exist no validated, well-accepted models for benefit-risk assessment that have the appropriate degree of sophistication, and as a consequence no models are widely used by regulatory authorities or industry. The aim of the study was therefore to develop a new model for benefit-risk assessment of medicines using multi-criteria decision analysis (MCDA).
  
  
  METHODS
  The MCDA methodology was used for a systematic approach to assess the benefit risk ratio of medicines. The reasons for adopting this approach were (1) taking multiple benefit and risk criteria into account, (2) making a judgement on the evidence and potential uncertainty because of the incompleteness of evidence, and (3) making trade-offs of the benefits against risks.
  
  
  RESULTS
  It was demonstrated through a seven-step approach how MCDA is used to construct the model. Ten benefit and ten risk criteria were identified to form a value tree. Then fixed scales were established for all criteria and options on the criteria were scored. Weights were assigned for each criteria using swing-weighting. Finally sensitivity analysis was carried.
  
  
  CONCLUSIONS
  This novel approach based on MCDA has the potential for being applied as a new tool for judging and deciding on the benefits and risks, thereby helping regulators and industry in the development and approval of new medicines and their adequate use.
authors.affiliation: Regulatory Affairs Europe, Merck Sharp & Dohme (Europe) Inc, 5 Lynx Binnenhof, Brussels, B-1200, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: Mussen
authors.forename: Sam
authors.initials: S
authors.lastname: Salek
authors.forename: Stuart
authors.initials: S
authors.lastname: Walker
mesh_terms: D003661:Decision Support Techniques; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D017891:Pharmacoepidemiology / Q000379:methods*; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D004364:Pharmaceutical Preparations