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...

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Veröffentlicht in:	Developmental neuroscience 2006-01, Vol.28 (4-5), p.276-290
Hauptverfasser:	Natale, JoAnne E., Joseph, Jill G., Pretzlaff, Robert K., Silber, Tomas J., Guerguerian, Anne-Marie
Format:	Artikel
Sprache:	eng
Schlagworte:	Brain Injuries - psychology Brain Injuries - therapy Caregivers - psychology Caregivers - statistics & numerical data Caregivers - trends Child Clinical Protocols - standards Clinical Research 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
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Beschreibung
Zusammenfassung:	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.
ISSN:	0378-5866 1421-9859
DOI:	10.1159/000094154