Pediatric Drug Development: Outlook for Science-Based Innovation.

Abstract

There has been significant progress in pediatric drug development during the past 15 years. Results from 1,200 pediatric studies have been submitted to the US Food and Drug Administration (FDA). Over 700 drug labels have been revised with information to guide pediatric use. Two international pediatric trial networks have been established.1,2 The failure rate for pediatric efficacy trials has fallen from over 40%3 to about 20%. Taken together, the outlook for pediatric drug development is positive.