Abstract
The purpose of this article is to discuss the issues associated with conducting clinical trials in pediatric spinal cord injury (SCI). The discussion will be limited to the areas of government regulation of pediatric participation in clinical trials, calcium metabolism, and the potential concerns for neurological and hormonal compromise in children with SCI. The guidelines regarding ethics and consent will be highlighted as recommended by the Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) section of pediatrics.
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