Adolescents in clinical trials

Abstract

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.