Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials

Abstract

This paper presents an examination of the process of recruitment in cancer clinical trials. This research was undertaken as part of a larger study which sought to assess the psychosocial impact of participation in phases I and II anti-cancer drug trials from the patient's perspective. Through a combination of in-depth interviews with 55 patients who were offered participation in a clinical trial, and reading ease assessments of the written information they were given, patients' experiences of recruitment to the trial and their perceptions of the informed consent process were obtained. The results indicate that patients decisions may be influenced by the way information was presented to them verbally and that the written information was difficult for them to understand. This aspect of the research identified the powerful influence of the verbal consultation when seeking consent for trial involvement, the lack of understanding patients had of what they were taking part in and the need to address the readability of the written information with which they are provided.