摘要
药物临床试验作为药物上市的前置和核心环节,药物临床试验项目在立项、审核、启动、实施、结题的各个环节中都长期存在对女性身体特性的忽视,绝大部分药物临床试验方案都以男性为范本,导致女性患者的治疗效果在IV期临床试验中表现不佳且其在采用药物治疗时副作用和致死率明显高于男性,这不但违反了男女平等的宪法基本权利保障,也侵害了女性的平等参与权以及知情权、健康权,故当通过CFDA、公益组织、媒体、药企的联合互动,保障女性在药物临床试验中的平等参与权,进而保障女性医疗权。
Drug clinical trials are the prerequisite and core link of drug marketing.Drug clinical trial projects have long ignored the physical characteristics of women in the various links of project approval,review,initiation,im⁃plementation,and conclusion.Most drug clinical trial programs are taking men as a model,which has led to the poor performance of female patients in phase IV clinical trials,and the side effects and fatalities in drug treatment are sig⁃nificantly higher than those of men.This violates not only the basic constitutional rights and norms of equality be⁃tween men and women,but also women's rights to know and health.Therefore,the joint interaction of CFDA,non-profit organizations,media,and pharmaceutical companies should be used to protect women's equal rights in drug clinical trials,thus further protect women's medical rights.
出处
《医学与法学》
2022年第2期36-41,共6页
Medicine and Jurisprudence
关键词
药品研发
女性医疗权
平等权
研发试验
drug research and development
women's medical rights
equal rights
research and development experiment
