Clinical trials in pediatric traumatic brain injury: unique challenges and potential responses

Dev Neurosci. 2006;28(4-5):276-90. doi: 10.1159/000094154.

Abstract

In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.

Publication types

  • Meta-Analysis
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Brain Injuries / psychology
  • Brain Injuries / therapy*
  • Caregivers / psychology
  • Caregivers / statistics & numerical data
  • Caregivers / trends
  • Child
  • Clinical Protocols / standards
  • Clinical Trials as Topic / ethics
  • Clinical Trials as Topic / standards*
  • Clinical Trials as Topic / trends*
  • Family / psychology
  • Humans
  • Informed Consent / psychology
  • Informed Consent / standards
  • Outcome Assessment, Health Care / standards
  • Outcome Assessment, Health Care / trends
  • Patient Selection / ethics
  • Pediatrics / ethics
  • Pediatrics / standards*
  • Pediatrics / trends*
  • Practice Guidelines as Topic / standards*
  • Research Support as Topic / statistics & numerical data
  • Research Support as Topic / trends