CAJ | 학술논문

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。
재신약연발적전구화진정중，약물림상시험적질량관리공작환존재일사불족。간요소리료국외화국내약물림상시험질량관리역정，천술료신판자、연구자、약물림상시험궤구이급윤리위원회사개방면존재적문제。병차침대저사문제，제출가강 GCP 적배훈、가강대약물림상시험궤구적관리、가강윤리위원회재약물림상시험중적감관작용등건의。
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 trials.