中国医学伦理学2018，Vol.31Issue(2)：220-223,4.DOI:10.12026/j.issn.1001-8565.2018.02.15
临床试验中妊娠事件的预防与处理
Prevention and Treatment of Pregnancy Events in Clinical Trials
王晶 1刘宏伟 2蔡林芮 1李丰杉3
作者信息
- 1. 四川大学华西第二医院药物临床试验机构,四川 成都 610041
- 2. 出生缺陷与相关妇儿疾病教育部重点实验室,四川 成都 610041
- 3. 四川大学华西第二医院妇产科,四川 成都 610041
- 折叠
摘要
Abstract
The uncertain safety and effectiveness of test drugs and medical instruments in clinical trials might pose risks to the subjects, and pregnancy events emerging in clinical trials will increase the risks. At present, most of pregnancy events are recorded and reported as an adverse event, but due to their particularity, it is inappropriate to record and handle them with other adverse events. Pregnancy event closely is related to the interests of the sub-jects and the risk it might face, besides, it is also related to the interest and risk of their spouses and offspring. In order to handle pregnancy event, this paper elaborated responsibilities of researchers, sponsors and subjects accord-ing to the purpose of trials in three aspects, including experiment design, informed consent, and test expand, so that the interest of the subjects could get better protection.关键词
临床试验/妊娠事件/受试者保护Key words
Clinical Trials/Pregnancy Events/Subjects Protection分类
医药卫生引用本文复制引用
王晶,刘宏伟,蔡林芮,李丰杉..临床试验中妊娠事件的预防与处理[J].中国医学伦理学,2018,31(2):220-223,4.
