Clinical trials in pediatric traumatic brain injury: unique challenges and potential responses.
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.
Natale
JoAnne E
JE
Critical Care Medicine, Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA 95817, USA, and Department of Critical Care Medicine, Hospital for Sick Children, Toronto, Canada. joanne.natale@ucdmc.ucdavis.edu
Joseph
Jill G
JG
Pretzlaff
Robert K
RK
Silber
Tomas J
TJ
Guerguerian
Anne-Marie
AM
D001930:Brain Injuries / Q000523:psychology / Q000628:therapy*; D017028:Caregivers / Q000523:psychology / Q000706:statistics & numerical data / Q000639:trends; D002648:Child; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards* / Q000639:trends*; D005190:Family / Q000523:psychology; D006801:Humans; D007258:Informed Consent / Q000523:psychology / Q000592:standards; D017063:Outcome Assessment, Health Care / Q000592:standards / Q000639:trends; D018579:Patient Selection / Q000941:ethics; D010372:Pediatrics / Q000941:ethics / Q000592:standards* / Q000639:trends*; D017410:Practice Guidelines as Topic / Q000592:standards*; D012109:Research Support as Topic / Q000706:statistics & numerical data / Q000639:trends