No conflict of interest was declared.
A quantitative approach to benefit-risk assessment of medicines – part 1: the development of a new model using multi-criteria decision analysis†
Article first published online: 1 JUN 2007
Copyright © 2007 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Supplement: A Quantitative Approach to Benefit-Risk Assessment of Medicines
Volume 16, Issue Supplement S1, pages S2–S15, July 2007
How to Cite
Mussen, F., Salek, S. and Walker, S. (2007), A quantitative approach to benefit-risk assessment of medicines – part 1: the development of a new model using multi-criteria decision analysis. Pharmacoepidem. Drug Safe., 16: S2–S15. doi: 10.1002/pds.1435
- Issue published online: 21 JUN 2007
- Article first published online: 1 JUN 2007
- Manuscript Accepted: 14 MAY 2007
- Manuscript Revised: 22 JAN 2007
- Manuscript Received: 29 AUG 2006
- multi-criteria decision analysis (MCDA)
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).
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.
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.
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. Copyright © 2007 John Wiley & Sons, Ltd.