Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development

• Published in: Therapeutic innovation & regulatory science Vol. 53; no. 5; pp. 567 - 578
• Main Authors: Gamalo-Siebers, Margaret, Hampson, Lisa, Kordy, Kattayoun, Weber, Sebastian, Nelson, Robert M., Portman, Ronald
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.09.2019; Springer International Publishing; Springer Nature B.V
• Subjects: Adolescent; Bayes Theorem; Child; Children; Clinical trials; Clinical Trials as Topic - methods; Deep Learning; Drug development; Drug Development - methods; Drug Safety and Pharmacovigilance; Ethical standards; Extrapolation; Humans; Mathematical analysis; Pediatrics; Pharmacotherapy; Pharmacy; Research Design; Special Section: Pediatric Therapeutic Development: Original Article; United States; United States; pediatric trials; extrapolation; hierarchical model; Bayesian methods; matching

The conduct of pediatric clinical trials is legally required, monitored, and encouraged in major geographic areas such as the United States and Europe. However, because pediatric patients are considered vulnerable populations, they should only be enrolled as research subjects in a clinical trial if...