Therapeutic Optimism and Informed Consent in Phase I Oncology Trials

Abstract

Therapeutic optimism can be defined as the belief on the part of research subjects that they are more likely to receive a benefit and less likely to experience risk than others who are similarly situated. It can be distinguished from other forms of therapeutic misunderstanding including therapeutic misconception and therapeutic misestimation. Empirical evidence from subjects who participated in phase 1 oncology trials indicates that therapeutic optimism is high in a significant percentage of these subjects. The phenomenon of the optimistic bias (overestimation of benefit and underestimation of risk) underlies the therapeutic optimism. Among the risk factors that may dispose a subject to optimistic bias is the factor of perceived controllability in which the very act of consent may inform the optimism. Two theories in social psychology may be useful in explaining the optimistic bias. These are Gollwitzer’s mindset theory and Kahneman’s fast and slow thought system theory. According to these theories the implementation mindset and the fast thought system may in part explain the optimistic bias. Application of these theories to the informed consent process and using the empirical evidence derived from subjects in phase 1 oncology trials, a hypothesis is offered that the decision to participate in such trials is accompanied by an active rejection of the risk content of informed consent and occurs early in the informed consent process. Exploitation of the optimistic bias and steps that may be taken to curb this exploitation are discussed.