The human dimension in the assessment of medicines: Perception, preferences, and decision making in the European regulatory environment

There is clear evidence that individuals approach risky situations differently, and there are some discernible trends with regards to perceiving or taking risks. The influence of social/cultural factors on our interaction with technological advances, in this case medical advances, has been openly acknowledged by risk researchers for decades, but only for laypeople. Experts have escaped similar scrutiny into the factors that influence their views on potential risks, and have been assumed to focus only of the probability and the magnitude of the risk, effectively closing the door to real dialogue with patients and other non-experts. The first three chapters of this thesis present the results of field studies aimed at evaluating the psychometric paradigm among a group of experts who conduct risk evaluation within the pharmaceutical regulatory environment. The fourth chapter, provides results of a multi-criteria decision support tool evaluated within the pharmaceutical regulatory environment and shows that it is feasible to integrate such methods within the existing benefit-risk evaluation process. The two final chapters present an advance on the previous chapter by using a multi-criteria approach to capture preferences for treatment outcomes among patients and among experts (medical assessors) for ‘real’ treatment decisions. From this we can begin to quantify where the expert and the non-expert values on acceptable benefits and risks differ and where they converge. New paths for communication between all stakeholders in the field of medical research can be forged and the concepts of dialogue and shared decision-making realised within the field of pharmaceutical regulation.