Most of the psychopharmaceuticals used in children and adolescents have not gone through the clinical trials process; only slightly more have had research studies accomplished in this age group, particularly in younger children. Given the pressure to treat mood and behavioral disorders early, many of the medication decisions we make are based on experiences with adults. Therefore, it is prudent to review the potential problems involved in pediatric clinical research particularly as it relates to psychiatry. In this article we will examine current FDA and IRB policies, discuss the ethical issues involved in recruiting children and adolescents for these studies, as well as discuss reluctance of parents and their children to participate in clinical trials. This will be based on a long history of academic clinical trial participation at LSUHSC in Shreveport, LA. Awareness of these issues will hopefully facilitate greater research in our younger patients, leading to improved treatment options for mental illnesses.
Keywords: Clinical trials, research, psychiatry, medications, IRB, FDA, children
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