Understanding cognitive processes behind acceptance or refusal of phase I trials

Abstract

Participation in phase I trials gives patients the chance to obtain control over their disease by trying an experimental therapy. The patients' vulnerability, the informed consent process aiming at understanding the purpose and potential benefits of the phase I trial, and the complexity of the studies may impact the patient's final decision. Emotionally difficult health conditions may induce patients to succumb to cognitive biases, allocating attention only on a part of the provided information. Filling the gap in patients' information process can foster the implementation of strategies to help physicians tailor clinical trials' communication providing personalized support and tailored medical information around patients' need, so avoiding cognitive biases in patients and improving informed shared decision quality. The aim of the present review article focuses on the analysis of cognitive and psychological factors that affect patients' decision to participate or not to early phase clinical trials.

Keywords: Cognitive bias; Patient acceptance; Patient refusal; Phase I trial; Psychological factors.