我国药物临床试验受试者保护问题研究.PDFVIP

·药事管理· 我国药物临床试验受试者保护问题研究 ＊ # 严 康 ，沈爱玲（南京中医药大学经贸管理学院，南京 210023） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2015）01-0012-03 DOI 10.6039/j.issn.1001-0408.2015.01.04 摘 要 目的：促进药物临床试验受试者规范化管理，提出加强受试者保护的方法。方法：介绍国内外药物临床试验的发展趋势 与我国药物临床试验中受试者保护的突出问题。结果与结论：我国药物临床试验市场潜力巨大，国外药物临床试验正逐渐向我国 转移，我国受试者样本丰富且临床试验成本较低。但受试者保护存在诸多问题，如受试者在试验中处于弱势地位、需要承担巨大 的风险、常易受到招募广告的误导、中途退出后权益得不到保证等。建议建立保护临床药物受试者权益的第三方组织，应用风险 管理方法衡量受试者的风险受益比；伦理委员会应加强对药物临床受试者招募广告的审核，发挥研究者对受试者权益的保护作用 等措施。 关键词 临床试验；受试者；保护 Study on Subjects Protection of Drug Clinical Trials in China YAN Kang ，SHEN Ai-ling （School of Economic and Management ，Nanjing University of TCM ，Nanjing 210023，China ） ABSTRACT OBJECTIVE ：To improve the standardized management of the drug clinical trial subjects and put forward the meth- ods to protect the subjects. METHODS ：The development trend of domestic and foreign drug clinical trials were introduced ，and the problems of the subjects protection of drug clinical trial in China were also introduced. RESULTS CONCLUSIONS ：Drug clinical trials market shows tremendous potential in China ，and foreign drug clinical trials are transferring to our country gradually. There are abundant subject samples and less clinical trial cost in China. There are many problems in subject protection ，such as the subjects are in a vulnerable position ，bear high risk ，and are easily misled by the recruitment advertisement ，and right and interests are not guaranteed after dropping out of the trial ，etc. It is suggested to establish the rights and interests protection mechanism of the third party ，reasonably measure the venture-benefit ratio of the subjects by using risk management method ，strengthen the super- vision of drug clinical trials subjects recruitment advertisement by ethics committee ，and play the role of the researchers protecting subjects and so on. KEYWORDS Cl