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  • Title: Psychotropic drugs and paediatrics: a critical need for more clinical trials.
    Author: Tishler CL, Reiss NS.
    Journal: J Med Ethics; 2012 Apr; 38(4):250-2. PubMed ID: 22048850.
    Abstract:
    Many children in the USA are prescribed psychotropic drugs that have not been fully investigated in paediatric clinical trials. The common practice of prescribing psychotropic drugs off-label poses unknown and potentially serious short- and long-term consequences for these children. This paper briefly reviews the factors associated with the lack of paediatric clinical trials. We advocate a shift toward increasing paediatric trials with psychotropic drugs through a combination of adequate safety controls, additional reimbursement/compensation, a more organised and large-scale effort to collate results and outcomes across researchers and studies and additional public education about the importance of this research. In addition, we encourage the re-examination of the ethical standards for children's participation in phase 1 clinical trials as well as argue for longitudinal developmental studies on children who are prescribed off-label psychotropic drugs.
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