Document Type
Article
Publication Title
Journal of Law, Medicine, and Ethics
Publication Date
Spring 2020
ISSN
1748-720X
Page Number
129
Keywords
consent, parental permission, clinical trials, pediatric research
Disciplines
Health Law and Policy | Law
Abstract
Research with children lags far behind research with adults, even though research conducted with pediatric participants is critical to developing scientific knowledge that can benefit children. This is particularly apparent in the realm of pharmaceuticals. In a recent study, physicians prescribed an off-label medication to children in 18.5% of pediatric ambulatory care visits. In 74.6% of these cases, the medication was prescribed to treat a condition for which it did not have FDA approval, and in 17.6% of cases the medication was approved for the condition but not in the child’s age group. This widespread practice of using unapproved, and thus potentially ineffective and unsafe, medications in children continues due to longstanding challenges in stimulating pediatric research.
Numerous factors have contributed to delays in the pursuit of pediatric research. Economics has clearly played an important part in delays in pharmaceutical trials. Prior to 1997, drugs approved for adults rarely underwent clinical trials with children due to the high costs of pediatric clinical trials and lower potential for profits in the pediatric market. It is particularly telling that in order to incentivize drug companies to conduct pediatric clinical trials, it was necessary to promulgate regulations to make their medications more profitable in the adult market.
Recommended Citation
Ellen Wright Clayton, Kyle B. Brothers, and Aaron J. Goldenberg,
Online Pediatric Research: Addressing Consent, Assent, and Parental Permission, 48 Journal of Law, Medicine, and Ethics. 129
(2020)
Available at: https://scholarship.law.vanderbilt.edu/faculty-publications/1610