Children have the right to receive suitable cures, which are effective and safe. The efficacy and safety of a treatment can only be established after quality clinical trials, designed and performed on the population that will use it. More than half of the drugs commonly used in children (and 80% in neonatal age) have only undergone studies in adults, and the results derived have been adapted for their use in pediatrics (the so-called off-label use). Infants, children and adolescents have specific physiological features, which can make the drug ineffective or even toxic if not properly designed for these age groups.
Children are vulnerable individuals, and their parents or legal guardians must decide their participation in the interest and the wellbeing of their child. It is also important to listen and respect the willingness of the child.
Families, who decide to involve their child in a trial, contribute to the development of research, have an active role in the health of their child and can have access to cures before everyone and to therapies not commercially available yet.
One reason that drives parents to enter into a clinical trial is also to help other families who deal with similar situations. Today, our children have a better quality of life and are protected from many diseases once lethal, because of parents in the past have made the decision to allow their children to participate in a clinical trial.