Placebo-controlled trials in pediatric urology: a cautionary view from an ethical perspective.
The ethical dispute regarding placebo-controlled trials is discussed in this review. Important issues, such as clinical equipoise, fiduciary obligation and middle ground theory, are examined in the context of pediatric urology clinical research. After reviewing the literature, the authors summarize specific indications for placebo-controlled trials in pediatric urology, and emphasize that physicians have ethical and moral obligations to patients, in the sense that one should carefully plan and conduct such trials in order to gain clinically important information without exposing children to undue risks.