Overcoming The Complexities Of Pediatric Clinical Trials

Although children make up 27% of the world’s population, at least 50% of all drug products may still lack labeling with pediatric information. Drugs without proper clinical research in pediatric patients greatly raises the risk of unexpected adverse events: in 2008, 211,209 visits to the emergency room were by children 12 or younger due to adverse drug reactions.

The evolution in pediatric legislation,¹ a growing commitment to pediatric studies by the pharmaceutical industry, and a renewed interest in therapeutics for rare diseases have increased the demand for timely, high‐quality, cost‐effective clinical trials in children.^2,3

However, approximately one in every five pediatric clinical trials fail^{4,5 .} A 2016 study shows that over a three-year period (2008 -2011), more than 77,500 children participated in studies that contributed little or nothing to advance treatments for their illnesses because the research disappeared from scientific view⁶: what challenges cause these failures and how can they be overcome?