Ethical consideration in the design and conduct of pediatric clinical trials

All healthcare professionals and medicines developers have an ethical obligation to promote the physical, psychological, social, and spiritual health of children. Similarly, children have a right to receive good quality health care, access to new innovative therapies through relevant clinical research, and to be heard and participate in the decision-making process. Medical research involving children as trial participants must follow the highest scientific and ethical standards in all phases of research to promote the interests, rights, and needs of children and their families. Children should not be excluded from pediatric clinical trials, but all trial protocols must be designed in a way that the children are protected from unnecessary risks or burden. This chapter concentrates on the ethical requirements, providing information on how to design and perform clinical trials in children of all age groups with ethically accepted methods.