Adolescents in clinical trials.
Drug development is a lengthy, costly, and complex process, with clinical trials essential for characterizing dosing, safety, and efficacy in treated populations. After regulatory approval, aggressive marketing ensures that most drugs are used by a broad spectrum of ages, genders, races, and ethnic groups. Unfortunately, not all groups are adequately represented in clinical trials; adolescents are commonly overlooked. This commentary explores how adolescents are considered during drug development, with a special focus on the influence of inherent psychosocial, biological, ethical, and regulatory issues in their recruitment and participation in clinical studies leading to drug licensing.
Kapogiannis
B G
BG
Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research for Mothers and Children, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, MD, USA.
Mattison
D R
DR
D000293:Adolescent; D000295:Adolescent Medicine; D000367:Age Factors; D002986:Clinical Trials as Topic; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D020380:Needs Assessment; D018579:Patient Selection; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010601:Pharmacology, Clinical / Q000592:standards* / Q000639:trends; D011584:Psychology; D018570:Risk Assessment; D014481:United States
D004364:Pharmaceutical Preparations