title: Pharmacologic studies in vulnerable populations: Using the pediatric experience.
abstract: Historically, few data exist to guide dosing in children and pregnant women. Multiple barriers to inclusion of these vulnerable populations in clinical trials have led to this paucity of data. However, federal legislation targeted at pediatric therapeutics, innovative clinical trial design, use of quantitative clinical pharmacology methods, pediatric thought leadership, and collaboration have successfully overcome many existing barriers. This success has resulted in improved knowledge on pharmacokinetics, safety, and efficacy of therapeutics in children. To date, research in pregnant women has not been characterized by similar success. Wide gaps in knowledge remain despite the common use of therapeutics in pregnancy. Given the similar barriers to drug research and development in pediatric and pregnant populations, the route toward success in children may serve as a model for the advancement of drug development and appropriate drug administration in pregnant women.
authors.affiliation: Duke University Medical Center, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705; Department of Pediatrics, Duke University Medical Center, Durham, NC.
authors.forename: Kanecia
authors.initials: K
authors.lastname: Zimmerman
authors.affiliation: Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC.
authors.forename: Daniel
authors.initials: D
authors.lastname: Gonzalez
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
authors.forename: Geeta K
authors.initials: GK
authors.lastname: Swamy
authors.affiliation: Duke University Medical Center, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705; Department of Pediatrics, Duke University Medical Center, Durham, NC. Electronic address: michael.cohenwolkowiez@duke.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Cohen-Wolkowiez
mesh_terms: D000328:Adult; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003299:Cooperative Behavior; D004304:Dosage Forms; D004333:Drug Administration Routes; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008431:Maternal-Fetal Exchange; D056687:Off-Label Use; D010372:Pediatrics; D011247:Pregnancy; D037841:Pregnant People; D055553:Prescription Drugs / Q000493:pharmacokinetics*; D014481:United States; D014486:United States Food and Drug Administration; D035862:Vulnerable Populations
chemical_list: D004304:Dosage Forms; D055553:Prescription Drugs
keywords: children; drug development; drug trials; pregnancy