Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants'...

Using a qualitative approach, a total of 55 adult patients with advanced cancer were interviewed to examine their perceptions of participating in early phase anti-cancer drug trials. Patients' views and experiences were explored, primarily through the use of in-depth interviews, with additional information accessed through two widely-used quality of life questionnaires, at the beginning of, during and after trial participation. The picture of trial participation established from this work suggests that it is a dynamic process, that has a different meaning and impact according to the stage of trial involvement the patient is experiencing. The findings identify how patients perceived the offer of the trial, dealt with the trial treatment, and came to terms with trial conclusion. The insight and understanding that this work provides in terms of the impact of trial involvement over time as well as details of patients' information, decision-making and support needs has significant implications for cancer clinical trial management. The recommendations put forward in this paper focus on acknowledging the contribution trial participants make to cancer research, enhancing the process of preparing patients for trial participation, recognizing the need for continuing care, the incorporation of patients and potential patients' views into the clinical trials system, and educating the public about clinical trials.