A new paradigm for developing drugs in children: atomoxetine as a model.

When prescribing drugs for children, it is fundamental to acknowledge that they are distinct from adults with a different physiology and metabolism. They are also still maturing. The development of drugs with a primarily paediatric indication thus requires the trialling of these drugs in a paediatric population to assess safety, tolerability, and efficacy as appropriately as possible. When designing and running a paediatric clinical trial, a number of complexities must be addressed to ensure a successful study, including practical considerations, ethical issues, and tailoring communication appropriately to study participants and parents. The drug development process for atomoxetine, a novel, non-stimulant treatment for attention deficit/hyperactivity disorder (ADHD), encompassed a preclinical programme, initial trials in healthy adults, and a proof of concept trial in adults with ADHD. Open label and placebo controlled studies in paediatric patients followed, thus establishing the drug's safety and efficacy in children with ADHD. Further trials have addressed, and continue to address, wider aspects of the atomoxetine response in a paediatric setting.