Psychotropic drugs and paediatrics: a critical need for more clinical trials.

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.

journal_name

J Med Ethics

authors

Tishler CL,Reiss NS

doi

10.1136/medethics-2011-100003

subject

Has Abstract

pub_date

2012-04-01 00:00:00

pages

250-2

issue

4

eissn

0306-6800

issn

1473-4257

pii

medethics-2011-100003

journal_volume

38

pub_type

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