Abuse of Minors in Clinical Studies

This book critically examines Pediatric Drug Development (PDD), highlighting the ethical dilemmas, conflicts of interest, and practical challenges associated with drug studies in children and adolescents. While U.S. and EU laws mandate pediatric studies for new adult drugs, the physiological realities of growth and maturation often make such studies unnecessary or excessive, particularly in adolescents who are bodily mature well before legal adulthood. By analyzing the unintended consequences of well-intentioned regulations, the book questions the rationale behind PDD protocols and the validity of many studies conducted worldwide, offering a thought-provoking perspective for clinicians, researchers, and policymakers.

Key Features:

• Critical examination of Pediatric Drug Development (PDD) regulations and practices.
• Discusses ethical dilemmas and conflicts of interest in pediatric drug studies.
• Highlights physiological vs. legal considerations in adolescent drug research.
• Questions the necessity and validity of many pediatric studies, especially in older minors.
• Provides insight for clinicians, researchers, and policymakers involved in pediatric pharmacology.
• Encourages evidence-based reconsideration of current PDD approaches.