Abstract

Children and pregnant women are often excluded from clinical research. This has resulted in a paucity of evidence on how medicines work for fetuses, neonates, infants, and adolescents. It also raises bioethics, scientific, and public health concerns. For over half a century, doctors have prescribed medicines to children largely on the basis of how they work in adults, despite children’s varied physiologies and differences in how their bodies absorb and metabolize drugs. Regulations and legislation have led to an increase in the number of pediatric studies and to better drug labeling. However, children at all stages of their lives often remain “therapeutic orphans” owing to insufficient evidence about how medicines work for them.