Lessons learned in pediatric clinical research to evaluate safe and effective use of drugs in pregnancy.
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.
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.
Daniel
D
Gonzalez
Kim A
KA
Boggess
Michael
M
Cohen-Wolkowiez
D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D003198:Computer Simulation; D055808:Drug Discovery / Q000941:ethics* / Q000331:legislation & jurisprudence*; D005260:Female; D006801:Humans; D008962:Models, Theoretical; D015337:Multicenter Studies as Topic; D010372:Pediatrics; D010599:Pharmacokinetics; D000069437:Pharmacological Phenomena; D011247:Pregnancy