title: Special population considerations and regulatory affairs for clinical research.
abstract: Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of "special population" exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld.
authors.affiliation: Department of Surgery, School of Medicine, University of California, Davis, Sacramento, CA, USA.
authors.forename: Kristin N
authors.initials: KN
authors.lastname: Grimsrud
authors.affiliation: Division of Clinical Pharmacology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Catherine M T
authors.initials: CM
authors.lastname: Sherwin
authors.affiliation: Division of Clinical Pharmacology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: Constance
authors.affiliation: Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA.
authors.forename: Casey
authors.initials: C
authors.lastname: Tak
authors.affiliation: Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, PA, USA.
authors.forename: Athena F
authors.initials: AF
authors.lastname: Zuppa
authors.affiliation: Division of Clinical Pharmacology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA ; Department of Pharmacology and Toxicology, College of Pharmacy, University of Utah, Salt Lake City, UT, USA ; Division of Adolescent Medicine, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Spigarelli
authors.affiliation: Division of Adolescent Medicine, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Mihalopoulos
keywords: Geriatrics; human subject research; pediatrics; pregnancy; regulations