Some opinion of pregnancy test in the drug clinical trial
10.13699/j.cnki.1001-6821.2017.07.001
- VernacularTitle:关于药物临床试验中妊娠检测的若干思考
- Author:
Qiang ZHANG
1
;
Ping MENG
;
Ai-Lian SHAN
Author Information
1. 兰州军区兰州总医院国家药物临床试验机构
- Keywords:
drug clinical trial;
pregnancy test;
traceability;
male subject;
subjects education
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(7):579-581,598
- CountryChina
- Language:Chinese
-
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.
