Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement

Pediatrics
May 2012, VOLUME 129 / ISSUE 5
http://pediatrics.aappublications.org/current.shtml

Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement
Scott C. Denne
Pediatrics 2012; 129:e1320-e1321

Extract
Performing research studies in children to evaluate drugs and other therapies is critical to providing proper pediatric medical care. For too long, medication use in children has been limited to extrapolation from adult studies or off-label use for indications that have not been properly evaluated in children. It has been less than 20 years since practical measures have been put in place to ensure that the necessary research evaluating therapies is more consistently carried out in children. Prompted by the American Academy of Pediatrics and other pediatric organizations, the Food and Drug Administration (FDA) in 1997 and the National Institutes of Health (NIH) in 1998 initiated policies designed to increase the number of children in research studies, including drug trials.1,2 Along with subsequent legislation, including the Best Pharmaceuticals for Children Act (2002), and the Pediatric Research Equity Act (2007), the initiatives by the FDA and …