RESUMO
Children’ s ability to dispose of drugs and the efficacy/safety of drugs for children differ from those adults as children are in the process of growth and development. In general,medication for children in a certain age group should be supported by clinical trial data from the corresponding pediatric population. However,compared with clinical trials in adults,children’s clinical trials have many challenges such as the ethical limitation and the difficulty in enrolling subjects. As a result,the use of drugs for children is often not formally approved by the drug regulatory authori- ties. At present,researchers tend to apply modeling and simulation to clinical trials,and conduct prospective studies be- fore the clinical use of drug to predict the optimal dosage regimen for children of different ages. In particular,there have been several successful cases in determining the optimal sample size for clinical trials based on the optimal design theory, optimizing sampling time point using the prior information from modeling,and processing sparse data by the Bayesian principle. This paper summarizes the role of modeling and simulation in pediatric clinical trials by reviewing previously reported clinical trial literature.