儿童临床试验若干问题的体会

儿科临床试验与成人临床试验相比有着很多特殊性。探讨了儿科临床试验知情同意的特点和要求，说明了受试儿童在临床试验中应该得到的伦理关怀，分析了如何从伦理保护角度选择合适的儿童受试者．指出了伦理委员会在试验过程中应进行伦理跟踪和伦理评价，明确了儿科临床试验方案设计的几个注意点，分析了儿科临床试验中受试者难以募集和依从性差的原因及其对策。

On Some Issues in Pediatric Clinical Trails

There are many differences between pediatric clinical trails and general clinical research. This paper discusses specialties and requirements of the pediatric clinical trails, clarihes ethical concerns children deserve m the clinical research, analyses the admission threshold for ethical protection that ethics committee should carry out ethical trails and appraisals throughout key issues in protocol design, analyses the reasons for dissatisfactory collection among children subjects, points out the research process, identifies some and compliance of children subjects,and comes up with concerned countermeasures.