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European Pharmaceutical Contractor

For the Children

Most drugs prescribed for children have not undergone a paediatric trial. Only 20 to 30 per cent of drugs approved by the Food and Drug Administration (FDA) are labelled for paediatric use, so by necessity doctors have routinely given drugs to children ‘off label’.

This means the drug hasn’t been studied in children in adequate, well-controlled clinical trials approved by the agency. If adequate investigations are not conducted to provide data for evidencebased treatment for paediatric patients, each patient essentially becomes an uncontrolled experiment. FDA believes it is crucial to paediatric public health for therapies that will be used in children to have evidence-based paediatric information in the labelling.

The historical lack of paediatric drug testing is due to a combination of factors. Ethical concerns such as patient selection, placebo use and consent/assent made many people uncomfortable with studying paediatric patients in clinical trials. Paediatric trials also require specialised research centres equipped and staffed to handle the paediatric population. In addition, sufficient numbers of paediatric patients with a given condition are often limited, and accumulating enough patients for a study may require many sites and a longer course of time.


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Lisa L Mathis is a board certified paediatrician who works in the Office of New Drugs in the Center for Drug Evaluation and Research as the Associate Director for the Pediatric and Maternal Health Staff, FDA. The Pediatric and Maternal Health Staff works to provide clinicians and patients with information needed to appropriately use medications in children, and during pregnancy and lactation.
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