中国临床药理学杂志2017，Vol.33Issue(7)：579-581,598,4.DOI:10.13699/j.cnki.1001-6821.2017.07.001
关于药物临床试验中妊娠检测的若干思考
Some opinion of pregnancy test in the drug clinical trial
张强 1蒙萍 1单爱莲2
作者信息
- 1. 兰州军区兰州总医院国家药物临床试验机构,兰州730050
- 2. 北京大学第一医院临床药理研究所,北京100034
- 折叠
摘要
Abstract
During the screening process,the women at childbearing age have to take the pregnancy test in order to avoid the harm of some new drugs for fetal or neonatal.However in the clinical process,some researchers have doubts,for example,if it is necessary for all the childbearing subjects to take a pregnancy test while some subjects do not or have no chance to get pregnant.Whether the regular urine pregnancy test that cannot indeed trace the source could reach the requirements of drug clinical trials'verification? In most clinical protocols,there is such a brief description like pregnancy or lactation women,is it rigid? Therefore,we put forward our own opinion and suggestion after investigating relevant laws,regulation and literature and combining the pregnancy description of 92 drugs clinical trial protocols.We suggest that the childbearing age women who do not or have no chance to get pregnant by asking the medical history do not take the pregnancy test.In the exclusion standard we should describe all the situation of pregnant in detail including the requirement and limitation for mail.What's more,it is also important to strengthen the education of the subjects and pay special attention on the subjects who will get pregnant in a short period for protecting their right and finishing the experiment.关键词
药物临床试验/妊娠检测/溯源/男性受试者/受试者教育Key words
drug clinical trial/pregnancy test/traceability/male subject/subjects education分类
医药卫生引用本文复制引用
张强,蒙萍,单爱莲..关于药物临床试验中妊娠检测的若干思考[J].中国临床药理学杂志,2017,33(7):579-581,598,4.
