Drug Safety

, Volume 15, Issue 1, pp 1–7 | Cite as

Concepts in Risk-Benefit Assessment

A Simple Merit Analysis of a Medicine?
  • I. Ralph Edwards
  • Bengt-Erik Wiholm
  • Carlos Martinez
Leading Article


The term ‘benefit-risk ratio’ is often used as a general term linked to the use of a medicine. To balance risk and benefit is, however, a very complex exercise. For most medicines the benefits are limited to a few indications and for an individual patient there is usually only a single benefit sought but the potential risks are multiple.

Perceptions of risks versus benefits are influenced to a great extent by the context in which they occur. Thus, perception of risk may be different to actual risk. In the end in any given situation, the acceptable risk-to-benefit balance is an individual judgement on the part of the patient or the prescriber.

For newer medicines, where there is likely to be limited experience, conser-vative estimates of the overall merit seem preferable so that the prescriber will use the drug critically. Subsequently, re-evaluation of the risk-to-benefit balance is necessary as greater knowledge of efficacy and adverse effects is acquired.

It is possible to provide a general ‘principle of threes’ structure for a merit assessment based upon the concepts of seriousness, duration and incidence as related to disease indication, disease amelioration by a medicine, and the adverse effects ascribed to the medicine. This allows a rapid first comparison of medicines for a given indication.

In using this general conceptual model in a transparent fashion for a given hypothesis and context, it is possible to identify the essential data used and assumptions involved that make up a merit statement. The quality and value, particularly of risk data, is problematic. Risk perception is an issue that needs to be clearly identified alongside a merit analysis. A simple merit assessment should pave the way for more focused studies.


Adis International Limited Spontaneous Report Risk Data Risk Benefit Analysis International Drug Monitoring 


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Copyright information

© Adis International Limited 1996

Authors and Affiliations

  • I. Ralph Edwards
    • 1
  • Bengt-Erik Wiholm
    • 2
  • Carlos Martinez
    • 3
  1. 1.WHO Collaborating Centre for International Drug MonitoringUppsalaSweden
  2. 2.Adverse Drug Reactions Section, Division of Drug EpidemiologyInformation and Inspection, Medical Products AgencyUppsalaSweden
  3. 3.Clinical ResearchHoechst AGFrankfurt/MainGermany

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