Enhancing cancer clinical trial management: Recommendations from a qualitative study of trial participants' experiences

Using a qualitative approach, a total of 55 adult patients with advanced ca ncer were interviewed to examine their perceptions of participating in earl y phase anti-cancer drug trials. Patients' views and experiences were explo red, primarily through the use of in-depth interviews, with additional info rmation accessed through two widely-used quality of life questionnaires, at the beginning of, during and after trial participation. The picture of tri al participation established from this work suggests that it is a dynamic p rocess, that has a different meaning and impact according to the stage of t rial involvement the patient is experiencing. The findings identify how pat ients perceived the offer of the trial, dealt with the trial treatment, and came to terms with trial conclusion. The insight and understanding that th is work provides in terms of the impact of trial involvement over time as w ell as details of patients' information, decision-making and support needs has significant implications for cancer clinical trial management. The reco mmendations put forward in this paper focus on acknowledging the contributi on trial participants make to cancer research, enhancing the process of pre paring patients for trial participation, recognizing the need for continuin g care, the incorporation of patients and potential patients' views into th e clinical trials system, and educating the public about clinical trials. C opyright (C) 2000 John Wiley & Sons, Ltd.