Drug research and treatment for children in Canada: A challenge.

Historically, children have been 'therapeutic orphans'. Many drugs have not been studied or labelled for use in children and adolescents, making the development and definition of optimally safe and effective drug therapies for the paediatric age group an ongoing challenge. Over the past decade, networks have developed in the United States and Europe to enhance drug research for this group, while no comparable evolution has occurred in Canada. The present statement provides context for the Canadian situation and makes recommendations that address two pressing needs: for more drug research focused on Canadian children and adolescents, including dedicated support for such research; and for increasing human capacity to undertake targeted studies. These initiatives should be undertaken collaboratively, nationally and internationally, and include strategic, innovative approaches to the unique problems and ethical issues posed by drug research in this population.