NB. Please note that if you are outside North America, the embargo for LANCET press material is 0001 hours UK Time 27 August 2004.
An editorial in this week's issue of THE LANCET comments on the recent UK Government's announcement of a new initiative to encourage the development of more medicines designed specifically for use in children. "Off-label" use is common in paediatrics, which can mean that drugs have not been tested at all in children or in a particular age group, or are given by an unlicensed route, for an unlicensed indication, or at an unlicensed dose. As Patrina Caldwell and colleagues explain in a review article in this week's issue (p 803), doing clinical trials in children is difficult for many reasons and requires specific expertise and extraordinary commitment by all those involved. The editorial comments: 'With drug companies generally uninterested because of low market value and with harsh competition from adult studies for funding by the public or charity sector, research grants for clinical trials in children are very hard to come by. So any special attention to, and encouragement for, paediatric research is very welcome.'
The absence of a legal obligation on companies to produce information on drug trials among children is seen as a weakness of the new proposal: 'Without legislation, companies will not voluntarily undertake paediatric trials because they are politely encouraged to do so'.
The editorial concludes: 'Another part of the UK Government's initiative is the investment of part of additional £100 million announced in April, 2004, into a new research network on medicines in children. In addition to medicines in children, research networks will initially cover cancer, mental health, diabetes, stroke, and Alzheimer's disease. An effective research network for paediatric trials with a wider remit, rather than just for medicines in children, would be an extremely valuable step forward in an area where data are lacking and disease prevention, diagnosis, treatment, and care are all too often based on no more then anecdotal evidence. As presented, this new initiative falls a long way short of what children deserve: centre stage for acquiring research-based evidence.'
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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