Stories about: Pediatric Research Equity Act

Only a third of Federally mandated ‘post-marketing’ pediatric drug trials are complete

too few mandated pediatric drug trials are getting done
Despite new requirements, pediatric drug trials largely aren’t getting done. (ADOBE STOCK)

The FDA requires clinical studies of new drugs in pediatric populations, since many drugs developed for use in adults are also used in children. These studies are often “post-marketing” trials after the drug is approved in adults. But an audit by researchers at Boston Children’s Hospital found that only about a third of these mandatory trials were completed within an average of seven years. As a result, most new drug labels continue to lack child-specific information, and most FDA-approved drugs remain untested in children.

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