Pediatric stroke: Opportunities and challenges in planning clinical trials.
A conference entitled "Towards the establishment of clinical trials in pediatric and newborn stroke" assembled stroke animal model researchers, pediatric stroke researchers, adult stroke trialists, and members of the Food and Drug Administration and National Institute of Neurological Disorders and Stroke to focus on the obstacles and opportunities for conducting randomized trials in pediatric stroke. The need for good prospective clinical data in newborn and pediatric stroke in regard to outcome and recurrence risk was stressed. For clinical trials, there should be a scientific rationale. Preclinical data should be as promising and as complete as possible. Adult data should be explored, both positive and negative. For medication trials, reasonable safety and bioavailability data for the agent in question should be available. Commitment of researchers, collaboration with colleagues in primary care, emergency rooms, and intensive care units, and most importantly the willingness to participate of children and their families will all be crucial. Most children with cancer in the United States are enrolled in clinical trials and have an outcome superior to the adult patient with cancer, who is less likely to be enrolled in a trial. We should strive for enrollment and outcome results in pediatric stroke similar to those found in pediatric oncology trials.
Pavlakis
Steven G
SG
Maimonides Infants and Children's Hospital, Developmental Medicine and Child Neurology, Brooklyn, New York 11219, USA. spavlakis@maimonidesmed.org
Hirtz
Deborah G
DG
DeVeber
Gabrielle
G
D000328:Adult; D000818:Animals; D002648:Child; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D006801:Humans; D007231:Infant, Newborn; D020521:Stroke / Q000628:therapy*