药物临床试验存在的问题及对策.pdf

第29卷第11期 卫生软科学 Vol.29 No.11 2015年11月 Soft Science of Health Nov.,2015 ● 卫生管理 ● 药物临床试验存在的问题及对策 1 2 3 陈月芹 ，闫 欣 ，王洪奇 （1.山西医科大学管理学院，山西 太原 030001；2.山西医科大学第一医院，山西 太原 030001； 3.山西医科大学人文学院，山西 太原 030001） 摘 要:在新药研发的全球化进程中，药物临床试验的质量管理工作还存在一些不足。简要梳理了国外和国内药物临 床试验质量管理历程，阐述了申办者、研究者、药物临床试验机构以及伦理委员会四个方面存在的问题。并且针对这 些问题，提出加强 GCP 的培训、加强对药物临床试验机构的管理、加强伦理委员会在药物临床试验中的监管作用 等建议。 关键词：药物临床试验；质量管理；伦理委员会 中图分类号：R194 文献标志码：A 文章编号：1003-2800（2015）11-0691-04 Research on problems and countermeasures of drug clinical trials 1 2 3 CHEN Yue-qin , YAN Xin , WANG Hong-qi ( 1. Management School of Shanxi Medical University, Taiyuan Shanxi 030001,China 2. The First Hospital of Shanxi Medical University, Taiyuan Shanxi 030001, China 3. Humanities and Social Sciences School of Shanxi Medical University, Taiyuan 030001, China) Abstract: During the globalization process of new drug research, there are some shortcomings in the quality management of drugs clinical trials. This paper briefly introduced the quality management development of foreign and domestic drug clinical trials and found out the problems from the aspects of sponsors, researchers, drug clinical trials institutions as well as ethics committee. In order to solve these problems, three suggestions were figured out: strengthening the training of GCP, strengthening the management of drug clinical trial institutions as well as strengthening ethics committee’s regulatory role in the drug clinical t