The decision-making process and benefit-risk assessment
Expert decision making in the European Regulatory Environment: How individual characteristics of medical assessors may influence regulatory decision-making
This thesis demonstrates that benefit-risk evaluations by regulatory assessors are significantly influenced by situational and personal characteristics of regulatory assessors. Regulatory decision-making bodies are believed to make rational evaluations of new medicines via which they come to an optimal weighing of medicines’ benefits and risks. In practice, however, benefit-risk decision-making appears to be influenced by factors other than those specific to the medicine under consideration.
We found that assessors’ personal characteristics, like gender and personality, influenced their risk perceptions and information on these characteristics could predict how risky or beneficial a medicine was perceived to be. Also, these personal characteristics influence risk perception differently in assessors than in laypersons. These results indicate that it might be wise to balance teams that review specific medicines on the basis of team members’ personal characteristics. This research also underlines the importance of using structured decision-making techniques and tools to mitigate the influence of assessors’ personal characteristics and shows that it is important to allow for transparency on these characteristics and how they may have influenced regulatory decision-making.
Results
- Beyer AR, Fasolo B, Phillips LD, De Graeff PA, Hillege HL. Risk perception of prescription drugs: Results of a survey among experts in the European regulatory network. In: Medical Decision Making, 2013. (journal publication)