基于药物研发与药物临床试验评价孕妇受试者的风险防控

Evaluation of Risk Prevention and Control for Pregnant Subjects Based on Drug Development and Clinical Trials

自从我国全面“二胎”生育政策实施以来,孕妇临床用药需求也随之增加,但是目前可为其提供的专用药品范围十分有限。为了解决这一问题,临床需加大加强新药研发的力度。孕妇作为一种特殊群体,做好孕妇受试者的风险防控、设计科学合理的药物临床试验方案并严格规范执行是孕妇用药研发需要解决的重要问题。本文现就孕妇作为受试者如何科学地参与临床药物研发这一内容进行探讨。

Since the implementation of China's comprehensive"second child"fertility policy,the demand for pregnant women's clinical medication has also increased.However,the range of specialty medicines available to them is currently very limited.In order to solve this problem,clinical efforts need to increase the intensity of new drug development.As a special group of pregnant women,it is an important issue for pregnant women's drug research and development to do a good job in risk prevention and control of pregnant women subjects,to design scientific and rational drug clinical trial schemes,and to strictly implement them.This article discusses how pregnant women as subjects participate scientifically in clinical drug development.