At present, more than 50% of drugs prescribed to children have not been tested in their age group.
1 Prescribers often have no alternative but to extrapolate to children the doses of drugs registered for adults. Historically the protection of children from research was often translated as simply excluding them from trials.
2 Research with this vulnerable population involves many unique ethical and legal considerations. Little is known about children’s capacities to meaningfully decide on research participation. To our knowledge, the correlation between competence and age in children has never been systematically investigated.