抄録
We previously reported the psychological issues experienced by parents whose children were undergoing pediatric clinical trials in Japan. The aim of this study was to investigate the psychological burden on parents whose children participated in clinical trials of inhaled corticosteroids with higher risk of adverse effects than other drugs. A questionnaire survey was conducted on 49 parents of 72 children who participated in randomized controlled studies using two types of active trial drugs. Of 49 parents, 23 (47%) responded to the questionnaire at the completion of the trials. Regarding the reason for participating in the trial, 39% of the parents responded that they believed the drugs would have a positive effect, 9% responded that they were convinced by the explanations given during the informed consent procedure, and 9% responded that they had faith in the investigators. At the completion of trials, 87% of the parents were satisfied with participation in the trials, and 87% responded that they would recommend the trials to other parents. However, there were controversial issues and complaints in their responses. Some responses included useful proposals for improving the trials in the future. In conclusion, in the special pediatric trials of inhaled corticosteroids, the parents' psychological belief that the drugs would prove successful and their faith in the principal investigator overcome their anxiety about possible adverse effects of the drugs, which are the motivating force that constitutes the basis for clinical trial implementation. These results show that a robust foundation of clinical care prior to clinical trial involving children ensures more satisfying results for all parties concerned.
