新药临床试验中医学伦理学问题的探讨  

Discussion on medical ethical issues in new drug clinical trials

作　　者：董荫良[1] 张丽旌[1] 车艳春[1] 钱兴丽[1] 段维国[1] 

机构地区：[1]中国医学科学院中国协和医科大学医学生物学研究所,昆明650118

出　　处：《药品评价》2004年第3期207-208,共2页Drug Evaluation

摘　　要：目的通过对新药临床试验中存在的医学伦理学问题的探讨,阐明在新药临床试验研究过程中,如何解决好试验阶段相关的医学伦理学问题。方法以相关的法律、法规、原则、规范以及社会伦理、道德为依据,探讨新药临床试验中的医学伦理学问题。结果临床受试者是一群生理甚至于心理均处于非正常状态的病人,因此在新药临床试验研究过程中,不但涉及到大量的技术问题,更重要的是存在相关的医学伦理学问题。结论在新药临床试验研究过程中,试验者必须执行和遵守相关的法律法规,解决好试验阶段相关的医学伦理学问题。Objective To clarify how to solve the relative medical ethical problems by discussing the medical ethical issues during new drug clinical trials. Methods Based upon the relative laws, regulations, principles and social ethics and morals, the medical ethical issues in new drug clinical trials were discussed. Results The volunteers are a group of patients with abnormal physiological and psychological states. Therefore, during the new drug clinical trials, not only a number of technical problems are involved, but also more important, the medical ethical issues are presented. Conclusion The people implemented trials should abide by relative laws and regulations so as to solve the related medical ethical problems during new drug clinical trials.

关 键 词：新药 临床试验 医学伦理学 

分 类 号：R-052[医药卫生]