[B]etween 50 and 90% of daily prescriptions for sick children use ‘off label’ drugs…legislations were introduced to stimulate the pharmaceutical industry to investigate the pharmacological effect and safety of both new and existing medicines in children. The quality of pediatric randomized controlled trials is often suboptimal, in part because guidance for their design and execution is lacking…evidence indicates that the quality of reporting of randomized controlled trials is less than optimal. The aim of this survey is to identify, classify, and appraise existing guidance on the design, conduct and reporting of pediatric clinical trials…There is a need for readily accessible, clear guidelines on how to design, conduct and report clinical drug trials in children in a scientifically valid and ethical way…