Abstract

Researchers at the New Mexico Veterans’ Affairs Health Care System and the University of New Mexico Hospital developed a clinical trials information handbook for patients and conducted a study to gauge its effectiveness. Participants from outpatient clinics were randomized to a control group and an intervention group. Members of the control group were given a questionnaire to complete to assess their knowledge of clinical trials. Members of the intervention group read the handbook prior to completing the questionnaire. The study showed that a clinical trials information handbook used during the informed consent process improved individuals’ knowledge about the process and decreased perceived risk from trial participation. This, in turn, could affect trial enrollment