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Adolescents in Clinical Trials
Author(s) -
Kapogiannis BG,
Mattison DR
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.191
Subject(s) - clinical trial , clinical pharmacology , drug development , broad spectrum , psychosocial , dosing , medicine , drug , ethnic group , pharmacology , psychology , psychiatry , political science , chemistry , combinatorial chemistry , law
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. Clinical Pharmacology & Therapeutics (2008); 84 , 6, 655–659 doi: 10.1038/clpt.2008.191