Adolescents in clinical trials

Clin Pharmacol Ther. 2008 Dec;84(6):655-9. doi: 10.1038/clpt.2008.191.

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.

MeSH terms

  • Adolescent
  • Adolescent Medicine*
  • Age Factors
  • Clinical Trials as Topic*
  • Drug Approval
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Male
  • Needs Assessment
  • Patient Selection
  • Pharmaceutical Preparations / administration & dosage*
  • Pharmacology, Clinical / standards*
  • Pharmacology, Clinical / trends
  • Psychology
  • Risk Assessment
  • United States

Substances

  • Pharmaceutical Preparations