Study on subject protection in clinical trials of pediatric drugs:from the perspective of ethical review
Children are a sensitive and special group,and their physical and mental conditions are significantly different from those of adults.There are many factors that need to be considered in the conduct of clinical trials of pediatric drugs.The clinical trial system of pediatric drugs in China is still in its infancy,with some immature aspects that may threaten the safety and rights of the subjects.Based on the characteristics of pediatric clinical trials and the protection needs of children as a special group of subjects,this study explored the aspects such as informed consent,research team building,and trial risk management,in order to provide theoretical references for the improvement of China's pediatric drug clinical trial system.
clinical trials of drugsethical reviewpediatric drugsprivacy protection
NETL
NSTL
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