Much has been written regarding the paucity and shortcomings of pediatric clinical trials, largely stemming from particular methodological and practical challenges of conducting research in children. In an effort to improve and expand the evidence-base for child health, a new initiative called Standards for Research in (StaR) Child Health was founded in 2009. The initiative involves an international group of researchers, methodologists, practitioners, regulators, and journal editors who seek to develop practical and evidence-based guidance to enhance the reliability and relevance of pediatric clinical research.

It was determined that the goals of StaR Child Health could best be met through the development of “standard development groups” (SDGs), which comprises an international group of experts in a given field. These groups would systematically work to address each of StaR Child Health’s identified priorities.

In the first article of this supplement, the StaR Child Health agenda and rationale is introduced. To date,...

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