Phase I trials in cancer patients: participants' perceptions.

There is controversy surrounding the ethics of performing phase I clinical trials with cancer patients and limited research concerning patients' attitudes when participating in such trials. The aim of this study was to determine how cancer patients perceive phase I clinical trials in reference to trial participation and trial information received. Cancer patients (n = 28) were interviewed 2-4 weeks after consenting to participate, using a questionnaire which contained open and closed questions. Responses were analysed using non-parametric statistical tests. The results demonstrated that although the majority of patients participated in experimental treatment because it offered hope that they might be helped, their expectations from the new drug were realistic. Patients found that there were benefits related to participating in phase I trials and felt that the amount and quality of both nursing and medical care was superior in a phase I trial as compared to standard treatment in non-experimental settings. There were varying opinions among patients with regard to information giving by nursing and medical staff. It can be concluded that phase I trials employing cancer patients can be ethical.