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."
For further information, please contact: ABPI Press Office 020 7747 1410