Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products among European medical assessors

By William Chin, PhD, Scientific Coordinator, EUCRAF

Have you ever wonder how do regulators at EMA evaluate the benefit and risk of medicinal drugs? What are the factors that contribute to the ability to judge the risks and benefits of the medicinal products? Do personality traits of the assessors influence their risk attitude and decision making? These are the interesting questions addressed in the research paper entitled "Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products: a field study of European medical assessors" published in the January 2015 issue of Value Health. 75 European medical expert assessors were assessed for their personality traits and risk attitudes with the aim of investigating whether there is a correlation between risk perception and benefit perception of medicinal products. The authors reported that the benefits and risks perception are inversely correlated among medical assessors. This is indicative of a heuristic (refers to experience-based techniques for problem solving) that may in some cases be veridical, that is, truly reflective of the assessment of the drug. This may also lead assessors to negate true benefits when there are high risks and prevent a balanced assessment. However the authors cautioned that this inverse relationship of benefits and risks should not serve as the sole explanation of the assessment process. The mental models of assessors are far more complex than previously assumed and that assessors rely on a complex interplay of risk attitudes and personality traits as well as the perception of the clinical data when assessing medicinal drugs. The practical importance of this research is how to manage these potential biases in the regulatory setting and how decision support tools can aid the transparency and minimize the impact of these traits.

Source

1. Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products: a field study of European medical assessors. Value Health. 2015 Jan;18(1):91-9.Beyer AR, Fasolo B, de Graeff PA, Hillege HL.