Protection of children and adolescents in psychiatric research: an unfinished business

In the past fifteen years, the treatment of psychiatric disorders of children and adolescents with mainly off-label psychotropic medications has increased so dramatically that it has become controversial. At the same time, an increasing number of mass clinical trials have been carried out with these same medications without applicable ethical guidelines, thereby exposing even more of these ill children and adolescents to potential harm. In addition, many research data that seemed unfavorable for marketing purposes have not been published or made otherwise available. Thus, both the integrity of clinical research and of the scientific basis of appropriate and safe psychiatric treatment of children and adolescents have been undermined. While the pharmaceutical industrys profit-motivated financial influence on clinical research seems to have been evident everywhere from the Food and Drug Administration (FDA) to academia, the US government has given additional impetus to clinical drug trials in children and adolescents.