| 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. |
