Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration

• Published in: Clinical pharmacology and therapeutics Vol. 104; no. 5; p. 983
• Main Authors: Green, Dionna J, Liu, Xiaomei I, Hua, Tianyi, Burnham, Janelle M, Schuck, Robert, Pacanowski, Michael, Yao, Lynne, McCune, Susan K, Burckart, Gilbert J, Zineh, Issam
• Format: Journal Article
• Language: English
• Published: United States 01.11.2018
• Subjects: Age Factors; Clinical Trials as Topic - methods; Drug Approval - methods; Drug Development - methods; Humans; Patient Selection; Research Subjects; Time Factors; Treatment Outcome; United States; United States Food and Drug Administration; United States
• ISSN: 1532-6535
• DOI: 10.1002/cpt.971

Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in ped...