药物临床试验,是新药研发中的重要环节,临床试验的科学准确,决定着创新药物是否能成功开发上市。所以,加强对药品研究过程中临床试验的监督管理,是越来越受关注的话题。过程监管不仅是关注研究进展全过程的规范性,更要关注在研究过程中受试者的权益保护问题。由于我国在药物临床试验管理方面相关的法规起步较晚,本课题将通过对药物临床试验中伦理审查管理模式的探讨、儿童用创新药物的知情同意如何完善以及如何建立在药物临床试验中的意外伤害保险制度等,探索更好地健全药物临床试验中受试者的权益保护机制。 Drug clinical trials, research and development of new drugs is an important part of clinical trials of scientific and accurate, determines whether the successful development of innovative drugs listed. Therefore, to strengthen the supervision and management of clinical trials in the process of drug research is a topic of increasing concern. Process supervision is not only concerned about the normative nature of the whole process of research progress, but also focuses on the subjects' rights and interests protection during the research process. Because of the late start of the relevant laws and regulations on drug clinical trial management in our country, this subject will discuss the management mode of ethical examination in drug clinical trials, how to improve the informed consent of children with innovative drugs and how to establish the accident in drug clinical trials Injury insurance system, to explore and better improve the clinical trials of drug subjects' rights and interests protection mechanism.