Archives of Disease in Childhood 2009;94:717-719
OTHER
Drug therapy
Leading articleRegistration of trials in children: update of current international initiatives
1 Laboratory for Mother and Child Health, Department of Public Health, "Mario Negri" Pharmacological Research Institute, Milan, Italy
2 Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby, UK
Correspondence to Chiara Pandolfini, Laboratory for Mother and Child Health, Department of Public Health, "Mario Negri" Pharmacological Research Institute, Via Giuseppe La Masa 19, 20156 Milan, Italy; pandolfini@marionegri.it
Accepted 5 May 2009
| The first 150 words of the full text of this article appear below. |
The last few years have been characterised by an increasing awareness of the inadequacy of children’s therapeutic options and of science’s insufficient knowledge in this area.1 2 The well-documented, frequent use of off-label and unlicensed medications in the young,3 4 with the increased risks it carries,5 can be seen as an indicator of the still limited knowledge on paediatric drug therapies. This lack of data is generally due to the greater difficulties inherent (ethical, practical and economic) in carrying out clinical trials in children. In such a context, given the scant evidence available on the safety and efficacy of drug therapies, the use of drugs in children is often inappropriate and not rational.6
With the awareness of the inadequate situation came the need to study paediatric research more closely to identify which disease areas are being addressed and which therapeutic needs of children are being ignored. The systematic
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