Children’s responses to drugs for many conditions are different than adults, yet few clinical trials that test the safety and effectiveness of new treatments involve pediatric patients, new research shows.
Scientists who conducted the study, presented at the Pediatric Academic Societies annual meeting in Boston this week, said it highlights a critical gap in pediatric health care and the need for more testing and oversight of new drugs administered to children.
"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," said Dr. Florence Bourgeois, a Harvard Medical School health specialist who led the new research.
For the study, Bourgeois and her colleagues identified all drug trials for 10 new medications used to treat common childhood conditions from 2006 to 2011 in ClinicalTrials.gov, a database of federally and privately supported clinical trials conducted around the world. Conditions included asthma, migraine headaches, schizophrenia, depression, diarrheal illness, lower respiratory infection, malaria, bipolar disorder and HIV/AIDS.
While pediatric patients account for nearly 60 percent of the cases of those conditions treated with drugs, only 12 percent of clinical drug trials involved children.
Funding sources appears to be a key factor, Bourgeois said. "We found that 58.6 percent of pediatric drug trials were conducted without any industry funding, relying solely on nonprofit organizations. In contrast, the majority of adult drug trials (64.7 percent) received industry funding."
Drug studies in children are important because children often respond differently to medications than adults. Clearer clinical evidence is needed to guide physicians in prescribing pharmaceuticals to children, the researchers concluded.
"As has long been suspected, children suffering from both acute and chronic diseases are not well-served by the current drug development and approval processes," said Dr. Kenneth Mandl, one of the study’s researchers.