抄録
Some controversial issues concerning pediatric clinical trials exist in Japan. The aim of this study was to investigate the psychological issues specific to pediatric clinical trials. We encounter difficulties in the clinical setting when conducting pediatric trials in Japan, because of the well established universal health insurance system with a strong focus on patient benefit and the close relationship between parents and children which is common among Asian people. In order to define the specific pediatric issues, we conducted a study on the psychology of parents whose children had participated in clinical trials of antibacterial antibiotics for acute otitis media or anti-allergic agents. In this study, a questionnaire survey was conducted on 51 parents of 61 pediatric trial participants. Twenty-five parents (49%) responded to the questionnaire at the completion of clinical trial. From the responses, we attempted to identify important issues that have to be resolved. The results indicated several unique and deep psychological issues in the parents. Some parents felt a sense of guilt for receiving a stipend as a result of their children's participation in the trials. During the trials, parents tended to hide their vague anxieties over their children's physical conditions from the investigators and the clinic staff. We will conduct further analysis to identify the most critical psychological factor, the solution of which will facilitate successful implementation of clinical trials involving children in the future.
