StaR Child Health: Developing Evidence-Based Guidance for the Design, Conduct, and Reporting of Pediatric Trials

Abstract

* Abbreviations: DMC — : data monitoring committee SDG — : standard development group StaR Child Health — : Standards for Research in Child Health WHO — : World Health Organization “Lack of research, poor research, and poorly reported research are violations of children’s human rights,” declared Dr Richard Horton in his plenary address to the audience of the first summit of Standards for Research in (StaR) Child Health. StaR Child Health was founded in 2009 to address the paucity and shortcomings of pediatric clinical trials. This initiative involves international experts who are dedicated to developing practical, evidence-based standards to enhance the reliability and relevance of pediatric clinical research. Through a systematic “knowledge to action” plan, StaR Child Health will make efforts to improve and expand the evidence-base for child health across the world. This article introduces the StaR Child Health agenda, the 11 initial priority topics that have been identified, and methods used to address these issues. Approximately 180 participants, including representatives from the World Health Organization (WHO), the US Food and Drug Administration, and the European Medicines Agency, gathered in Amsterdam for the first StaR Child Health summit in October 2009 (Table 1). The summit was held on the eve of the 20th anniversary of the adoption of the United Nations Convention on the Rights of the Child, which recognizes the right of all children “to the enjoyment of the highest attainable standard of health.”1 One impediment to achieving this universal right is the paucity and well documented shortcomings of pediatric research and more specifically clinical trials.2 It is recognized that the quantity, quality, and relevance of data involving children are substantially lower than for adults,3–5 despite data demonstrating that inadequate testing of interventions in children can result in ineffective or harmful treatments being offered or beneficial treatments being withheld.6 View this table: TABLE 1 Chronology of Key Events for StaR Child Health The mission of StaR Child Health is to improve the design, conduct, and reporting of … Address correspondence to Martin Offringa, MD, PhD, Senior Scientist and Program Head Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8. E-mail: martin.offringa{at}sickkids.ca