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Friday, February 18 2005
Moves towards ensuring that children benefit from medicines especially
tailored to their needs are spelt out in a new publication on paediatric
clinical trials from the Association of British Pharmaceutical Industry
(ABPI).
Clinical trials that involve children is one of the most difficult
ethical, medical and regulatory issues for the pharmaceutical industry.
The difficulty in conducting trials in young age groups is behind
a current shortfall in the range of medicines specifically formulated
for children.
The new book Current issues in paediatric clinical trials, which
originated from a major meeting on the subject, examines the principle
problems and offers some solutions. It features presentations from
NHS R&D director, Professor Sally Davies; Kedge Martin of patient
group Wellchild; clinical trial ethicist, Dr Hugh Davies and Dr
Julia Dunne of the Medicines and Healthcare products Regulation
Agency (MHRA).
"Currently more than 90 per cent of medicines used in newborns
and 45 per cent of medicines used in general paediatric care have
never been tested or licensed for use in that age group and are
used off-label by clinicians," said Dr Richard Tiner, ABPI
Director of Medicine.
"This situation needs to be changed but clinical trials in
so many age groups are expensive, the market for companies is small
and persuading parents to allow their children to participate is
understandably difficult."
Current issues in paediatric clinical trials (price: £10)
from ABPI Publications. To order a copy, email: publications@abpi.org.uk
or telephone: 020 7747 1446.
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