Quality of informed consent in cancer clinical trials: a cross-sectional survey

Background Investigators have to obtain informed consent before enrolling p articipants in clinical trials. We wanted to measure the quality of underst anding among participants in clinical trials of cancer therapies, to identi fy correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconcepti ons in participants and providers. Methods We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated in stitutions, and surveyed the provider who obtained each patient's consent. Findings 207 of 287 (72%) patients responded. 90% (186) of these respondent s were satisfied with the informed consent process and most considered them selves to be well informed. Nevertheless, many did not recognise nonstandar d treatment (74%), the potential for incremental risk from participation (6 3%), the unproven nature of the treatment (70%), the uncertainty of benefit s to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with co llege education, speaking only English at home, use of the US National Canc er Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. Interpretation Misconceptions about cancer clinical trials are frequent amo ng trial participants, and physician/investigators might share some of thes e misconceptions. Efforts to educate providers and participants about the u nderlying goals of clinical trials are needed.