Improving Development of Drug Treatments for Pregnant Women and the Fetus.
Improving Development of Drug Treatments for Pregnant Women and the Fetus.
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DOI：
10.1007/s43441-022-00433-w
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发表时间：
2022-11
影响因子：
1.5
通讯作者：
Thornton, Steve
中科院分区：
文献类型：
--
作者：
David, Anna L.;Ahmadzia, Homa;Ashcroft, Richard;Bucci-Rechtweg, Christina;Spencer, Rebecca N.;Thornton, Steve
将孕妇、育龄妇女和胎儿排除在治疗药物的临床试验之外是一个重大的全球公共卫生问题。这也是药物开发不公平的问题，因为怀孕是受保护的特征。目前，世界各地的一些机构正在对孕期药物的监管要求进行分析。在开发妊娠临床试验（针对孕妇和胎儿）方面的专业知识方面进行了大量投资，例如由国家儿童健康和人类发展研究所资助的产科-胎儿药理学研究中心。在如何定义和分级孕妇、胎儿和新生儿的临床试验安全性方面也取得了进展。利用计算机模拟人类妊娠生理学和药理学的创新方法也引起了人们的兴趣。利用磁共振成像、计算机心脏造影、血清循环胎胎盘蛋白和mRNA来评估胎儿健康和胎盘功能的新方法，可以更好地评估干预对母亲和胎儿的安全性和有效性。妇女和新生儿健康倡议的核心成果是促进怀孕试验数据的一致报告。与药房服务相结合的电子病历将提高药物流行病学和药物警戒研究的强度。对产科、胎儿和新生儿疾病采取了诸如调查计划和指定孤儿疾病等奖励措施。该审查描述了为更好地了解问题的严重程度和制定适用的解决方案而正在取得的进展。
The exclusion of pregnant populations, women of reproductive age, and the fetus from clinical trials of therapeutics is a major global public health issue. It is also a problem of inequity in medicines development, as pregnancy is a protected characteristic. The current regulatory requirements for drugs in pregnancy are being analyzed by a number of agencies worldwide. There has been considerable investment in developing expertise in pregnancy clinical trials (for the pregnant person and the fetus) such as the Obstetric-Fetal Pharmacology Research Centers funded by the National Institute of Child Health and Human Development. Progress has also been made in how to define and grade clinical trial safety in pregnant women, the fetus, and neonate. Innovative methods to model human pregnancy physiology and pharmacology using computer simulations are also gaining interest. Novel ways to assess fetal well-being and placental function using magnetic resonance imaging, computerized cardiotocography, serum circulating fetoplacental proteins, and mRNA may permit better assessment of the safety and efficacy of interventions in the mother and fetus. The core outcomes in women’s and newborn health initiative is facilitating the consistent reporting of data from pregnancy trials. Electronic medical records integrated with pharmacy services should improve the strength of pharmacoepidemiologic and pharmacovigilance studies. Incentives such as investigational plans and orphan disease designation have been taken up for obstetric, fetal, and neonatal diseases. This review describes the progress that is being made to better understand the extent of the problem and to develop applicable solutions.
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影响因子：
10
作者：
Blundell C;Yi YS;Ma L;Tess ER;Farrell MJ;Georgescu A;Aleksunes LM;Huh D
通讯作者：
Huh D
影响因子：
5.7
作者：
Ebner, Michael;Wang, Guotai;Vercauteren, Tom
通讯作者：
Vercauteren, Tom
影响因子：
3.4
作者：
Ayad M;Costantine MM
通讯作者：
Costantine MM
影响因子：
--
作者：
Arribas M;Roberts I;Chaudhri R;Geer A;Prowse D;Lubeya MK;Kayani A;Javaid K;Grassin-Delyle S;Shakur-Still H
通讯作者：
Shakur-Still H
影响因子：
39
作者：
Ferrara, Assiamira;Hedderson, Monique M.;Greenberg, Mara
通讯作者：
Greenberg, Mara