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More Drug Trials Needed for Conditions Affecting Kids: Review
Date:7/25/2012

rden for conditions such as malaria, diarrhea, HIV and depression, but only about 12 percent of clinical trials of treatments for these diseases include pediatric patients.

A number of professional organizations, including the Institute of Medicine, the American Academy of Pediatrics and the Royal College of Paediatrics and Child Health in England, have all published statements on the importance of evaluating medical treatments for children using randomized, controlled trials. A randomized, controlled trial, in which study participants are randomly chosen to either receive a treatment or not, is the gold standard for medical research.

"In some instances, it may be fine to extrapolate adult [dosing] information and scale down, but the way drugs are metabolized and excreted from the body is different in children," Bourgeois said. "Children might metabolize faster and need a greater dose than one might think just in terms of scaling down."

Children are also a special patient group because their bodies are still developing, and leaving them out of clinical trials means the possible effects of drugs on their growth go unaddressed, said review co-author Dr. Kenneth Mandl, an associate professor of pediatrics at Boston Children's Hospital.

In addition, some drugs taken by adults work the opposite way in kids, explained Albert Wertheimer, a professor of pharmacoeconomics at Temple University in Philadelphia.

"Drugs for [attention-deficit disorder] are stimulants that people take to stay up for a test, but when used in kids, they settle them down," Wertheimer noted.

For the review, Bourgeois and her colleagues reviewed all the clinical trials that were registered at ClinicalTrials.gov, the largest repository of clinical trials conducted around the world, between 2006 and 2011 for major pediatric conditions.

One reason for the lack of pediatric clinical trials could be who pays for them: The current study found that, while half of fu
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