ABSTRACT
A structured approach to benefit-risk evaluation is an essential tool for decision-making during pharmaceutical product development. Health Canada recently published a guideline to assist market authorization holders in developing a qualitative benefit-risk assessment for marketed medical products when requested. The survey focused on five key areas of benefit-risk assessment efforts:A future discusses the detailed results of this survey. The survey findings are informative to identify challenges and opportunities for benefit-risk planning processes within organizations. License applications in either the US or EU were rejected on grounds of quality, safety, or efficacy. Although this was intermittently referred to as benefits and risks, there was no internationally agreed approach to what this meant and how this should be achieved. Planning for incorporation of such data in clinical trials is important and will be time-consuming if measures require validation by the health authorities.
