More than a quarter century ago, pediatrician Harry Shirkey, MD, of Children’s Hospital in Birmingham, Ala, described infants and children as “therapeutic or pharmaceutical orphans” because relatively few drugs had been explicitly studied in pediatric patients (Shirkey. J Pediatr. 1968;72:119-120). Although the problem is well recognized, addressing it is no easy feat because of one incontrovertible truth: children cannot be protected from all research-related risks if they also are to benefit from medical treatments that can ameliorate or cure diseases. At some point, a child will be the first to receive a new drug or other therapy, so a delicate balance must be maintained between advancing knowledge that can help children and ensuring that risks are minimal and reasonable.
Hampton T. Experts Ponder Pediatric Research Ethics. JAMA. 2005;294(17):2148-2151. doi:10.1001/jama.294.17.2148