Related Experiment Video
Updated: Jun 11, 2026

Guidelines for Elective Pediatric Fiberoptic Intubation
Published on: January 18, 2011
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for
Gary J Noel1,2, Robert M Nelson3, Christina Bucci-Rechtweg4
1The Institute for Advanced Clinical Trials for Children, 9211 Corporate Blvd. Suite 260, Rockville, MD, 20850, USA. Gary.noel@iactc.org.
Abstract:
Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adolescents and older children in clinical trials before the safety and efficacy of these drugs are established for adults. However, it has been possible to design and execute phase 3 trials that combine adults with adolescents which are medically and scientifically sound and ethically justified. Based on this experience and considerations of the medical and scientific, ethical, and operation-related matters, the 2019 Pediatric Innovation Research Forum advocated for the position that adolescents routinely be considered for enrollment in phase 3 clinical trials. The Forum also concluded that exclusion of adolescents in adult pivotal trials occur only when a thorough evaluation of the target disease and the potential benefit and risks of the study intervention supports a delay in their involvement until after completion of clinical trials in adults.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Pharmacokinetics in Pediatric Patients: Drug Distribution
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Pharmacokinetics in Pediatric Patients: Drug Excretion

