ACCP is pleased to announce the publication of “Inclusion of Adolescents With Adults in Phase 3 Clinical Trials: Overview of the Current State and a Call for Action,” in ACCP’s The Journal of Clinical Pharmacology.
The primary objective of drug development from industry and regulatory perspectives is to enable patients’ access to safe and efficacious treatments in a timely manner. This objective is typically achieved through demonstrating efficacy and safety of novel pharmacological compounds in pivotal clinical trials. Currently, if a disease occurs in both pediatric and adult populations, a drug to treat such disease is usually evaluated first in adult phase 3 clinical trials before clinical trials are initiated in the pediatric population. Adolescent patients (defined as 12 to