StaR Child Health is a group of methodologists, clinicians and policy makers who seek to enhance the quality, ethics and reliability of pediatric clinical research by promoting the use of evidence-based standards or guidance for clinical studies with children.
THE NEED FOR SETTING STANDARDS
In April 2009, the StaR Child Health executive group was assembled which involved leading experts in pediatric clinical research and methodology. The first task was to conduct a systematic review of available guidelines for the design, conduct and reporting of research in children. This step, sponsored by the World Health Organization (WHO), found few relevant guidelines: http://www.who.int/childmedicines/publications/GUIDANCECHILDHEALTH.pdf, last accessed 4 January 2019.
Critical topics such as the need to consider appropriate stratification according to age or key aspects of development, how to get consent, dealing with small sample sizes, indications for trial safety committees, and the use of child-specific outcomes are not addressed in existing guidance. Most importantly, guidance is predominantly aimed at what should be done, but not how to do it.
Based on the results of this systematic review and a survey of leading child health methodologists and regulators, a list of priority issues regarding the design, conduct and reporting of pediatric clinical trials was compiled (See Standards). These topics were systematically addressed through standard development groups (SDGs), working groups that bring together experts and individuals interested in a given topic through invitation and subscription (See Our Team).