Children Neglected in Clinical Drug Trials

Aap.org: April 28, 2012.

BOSTON – Although children are more likely than adults to suffer from many diseases, few clinical trials are being conducted to test drugs in pediatric patients, according to a study to be presented Saturday, April 28, at the Pediatric Academic Societies (PAS) annual meeting in Boston.

Drug studies in children are important because children often respond differently to medications than adults. However, there is widespread concern about the lack of clinical evidence available to guide physicians in prescribing pharmaceuticals to children.

Florence Bourgeois, MD, MPH, assistant professor at Harvard Medical School, and her colleagues sought to measure how much research activity is devoted to conditions representing a high burden of pediatric disease. They identified all drug trials for the 10 highest burden conditions registered from 2006 to 2011 in ClinicalTrials.gov, a database of federally and privately supported clinical trials conducted around the world. These conditions included asthma, migraine headaches, schizophrenia, depression, diarrheal illness, lower respiratory infection, malaria, bipolar disorder and HIV/AIDS.

“We found that there is a large discrepancy between global disease burden in children and the amount of clinical trial research devoted to this population,” Dr. Bourgeois said.

While nearly 60 percent of the disease burden for high-priority conditions is borne by children, only 12 percent of clinical drug trials are pediatric trials. This discrepancy was greatest for conditions prevalent in middle- and low-income countries. Read More