摘要
目的为规范我国临床科研超说明书用药现状,提高研究的科学性和伦理性,保障受试者权益最大化。方法根据实际工作,并查阅国内有关临床科研超说明书用药存在的问题及解决途径方面的文献进行综合分析和讨论。结果结合临床科研超说明书用药过程中所面临的关于立法、监管、利益冲突和知情同意落实方面存在的问题,提出规范临床科研超说明书用药现状的思考和建议。结论明确合理超说明书用药的法律地位,加强监管,落实知情同意,鼓励药企和各级医疗机构开展药品上市后研究,合理分化风险,以改善临床科研超说明书用药现状,体现临床科研的科学性和伦理性,为医学事业的进步做出贡献。
Objective ： To standardize the present situation of off - label drug use in clinical scientific research, improve the scientific and ethical nature of research and ensure the maximization of the rights and interests of subjects. Methods： According to the actual work, this paper reviewed domestic literatures on the problems and solutions of the off - label drug use in clinical scientific research to conduct comprehensive analysis and discussion Results： In combination with the problems about legislation, supervision, conflicts of interest and informed consent implementation existing in the process of off - label drug use in clinical research, this paper put forward thinking and suggestions for standardizing the current status of off - label drug use in clinical scientific research. Conclusion ： It should clarify the legal status of rational off - label drug use, strengthen supervision, implement informed consent and encourage pharmaceutical companies and medical institutions at all levels to carry out the post -marketing study, rationally dift）rentiate risks, so as to improve the current status of off - label drug use in clinical scientific research, reflect the scientific and ethical nature of clinical scientific research and contribute to the progress of medical science.
作者
刘丹
曾圣雅
周吉银
LIU Dan;ZENG Shengya;ZHOU Jiyin(National Drug Clinical Trial Institution,the Second Affiliated Hospital,Army Medical University,Chongqing 400037,China)
出处
《中国医学伦理学》
2018年第11期1377-1380,共4页
Chinese Medical Ethics
基金
2017年陆军军医大学人文社会科学基金项目:临床科研项目伦理跟踪审查质量建设(2017XRW23)
关键词
超说明书用药
临床科研
受试者权益
Off - label Drug Use
Clinical Scientific Research
Rights of Subjects
