Psychosocial aspects of participation in early anticancer drug trials. Report of a pilot study.

Despite improvements in the treatment of many cancers, the need for effective new therapies is as great as ever. However, evaluating new drug treatments for cancer in clinical practice raises complex problems. Early trials of new drugs offer little in the way of therapeutic benefit, since their main aim is to identify toxic effects of the drug and subsequent doses for testing. The ethical and practical problems that these trials raise have received some attention in the literature. The main focus of previous studies has been the process of informed consent for trial participation, which has tended to reflect the perspective of the clinicians involved. Little attention has been given to patients' views in this context, and still less work has explored the total experience of clinical trial participation. In order to address these gaps in the literature, a research study was developed to explore the psychosocial aspects of participation in early anticancer drug trials from the perspective of the patient. This article reports the findings of a pilot study. The pilot study obtained the views of seven patients as they progressed through an anticancer drug trial. The informed consent process, the reasons behind decision-making concerning trial participation, and the impact of participation on the lives of the patients were explored, along with changing needs for information, care, and support as the trial progressed. Findings identify psychosocial aspects of clinical trial participation related to information, decision-making, and support from the perspective of those actually taking part.