Therapeutic misconception in clinical trials: fighting against it and living with it

Abstract

A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception». In this article, we describe the nature and extent of therapeutic misconception, which researchers can also experience. Its presence is especially important in phase 1 oncology trials and those with placebo group. To limit its occurrence, investigators have to ensure that participant information sheet are well written and to establish an effective and transparent discussion during the process of obtaining informed consent so that patients understand all aspects of their participation in the research and appreciate what this participation entails.

Keywords: Clinical research; Clinical trials; Consentimiento informado; Definición; Definition; Ensayos clínicos; Equívoco terapéutico; Hoja de información para el participante; Informed consent; Investigación clínica; Oncology; Oncología; Participants information sheet; Placebo; Prevalence; Prevalencia; Therapeutic misconception.