Gonzalez Daniel, Boggess Kim A, Cohen-Wolkowiez Michael
Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, and the Division of Maternal- Fetal Medicine, School of Medicine, University of North Carolina, Chapel Hill, and the Duke Clinical Research Institute and the Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.
Obstet Gynecol. 2015 Apr;125(4):953-958. doi: 10.1097/AOG.0000000000000743.
Children and pregnant women are vulnerable populations lacking clinical data to guide drug dosing. For children, over the past 15 years, the knowledge gap in pharmacokinetic, safety, and efficacy data has been narrowed as a result of the use of innovative clinical trial designs, minimal risk research methods, increased understanding of developmental pharmacology, multidisciplinary research teams, increased clinical pharmacology expertise and training, collaborative research networks, and critical legislative changes. This progress has not been observed to a similar degree for pregnant women. These two populations, however, share similar drug development challenges and, therefore, lessons learned in pediatric clinical trials can be leveraged to advance drug development in pregnant women.
儿童和孕妇是缺乏临床数据来指导药物剂量的弱势群体。对于儿童而言，在过去15年里，由于采用了创新的临床试验设计、最低风险研究方法、对发育药理学的理解增加、多学科研究团队、临床药理学专业知识和培训的增加、合作研究网络以及关键的立法变革，药代动力学、安全性和有效性数据方面的知识差距已经缩小。然而，孕妇群体并未取得类似程度的进展。不过，这两类人群面临相似的药物研发挑战，因此，儿科临床试验中吸取的经验教训可用于推动孕妇药物研发。
