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StaR Child Health Summit
Sadly, we know many important areas in child health lack the rigorous evidence for clear clinical decision making with uncertainties about what works and what is safe. This lack of evidence means that children may not receive treatments that are effective or continue to receive treatments that are not effective, or even work may be unsafe at times. Standards for Research in (StaR) Child Health was founded in 2009 because there are a lack of trials in child health, and those that are published are often lacking in important methodological standards. This initiative involves international experts who are dedicated to developing practical, evidence-based standards to enhance the reliability and relevance of pediatric clinical research.
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 to see what was available in guidelines for the design, conduct and reporting of research in children. Sadly there was little out there.
Approximately 180 participants, including representatives from the World Health Organization, the US Food and Drug Administration, and the European Medicines Agency gathered in Amsterdam for the first StaR Child Health summit in October 2009.
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 (Current Standards). These topics are being systematically addressed through standard development groups (SDGs), working groups that bring together experts and individuals interested in a given topic through invitation or volunteerism. A convener for each SDG reports to the StaR Child Health executive and is responsible for identifying tasks for the group, setting timelines and deliverables, coordinating activities, and leading the preparation of reports. General deliverables for the working groups are: a summary of the current evidence; a list of recommendations for the process of design, conduct and reporting of trials with children; identification of gaps leading to a research agenda; and a plan for dissemination and implementation of the findings and recommendations. The SDGs will recommend methodological research to advance the knowledge base as indicated. The draft reports from the SDGs are circulated for discussion among a larger group of researchers, regulators, and representatives from pharmaceutical industry. There will be an upcoming supplement in Pediatrics that will provide the latest guidance.
The vision for StaR Child Health is to become a virtual center that can provide resources and training related to the design, conduct, and reporting of clinical research in children. StaR Child Health’s initial goal is to create guidance for each of the topic areas described above. SDGs are currently compiling existing empirical evidence, identifying gaps, and setting a research agenda to provide a sound basis for guidance. StaR Child Health aims to evolve into a global child health research network dedicated to improving the design, conduct, and reporting of pediatric clinical trials and ultimately improving the quality of health care for children across the world. That is what the upcoming meeting in Winnipeg, May 7 to 8th will provide the latest update on the state of the science.
For more information and to REGISTER visit http://star.proreg.ca!