Clinical research in pediatric population: Scientific and ethical aspects

Children are a unique population with important differences in physical, physiological, and emotional differences from adults. Hence, research outcomes of studies conducted in adults cannot be extrapolated to pediatric population. However, there is scarcity of data on the safety and efficacy of new interventions in children, due to concerns about risks of research in children. It is vital to conduct scientifically robust and ethically sound observational noninterventional studies and interventional therapy clinical trials in children to provide supporting evidence for medical practices in the pediatric population, to advance understanding of diseases, and to provide quality health care. This is a brief review of scientific and ethical considerations in planning and conduct of clinical research in children.