Children Usually Excluded From Clinical Drug Trials: Study
MONDAY April 30, 2012 -- Children are more likely than adults to suffer from a number of diseases, but few clinical trials are conducted to test new drugs in children with these conditions, researchers have found.
In a new study, researchers looked at all clinical trials registered worldwide from 2006 to 2011 for drugs to treat these common conditions: asthma, migraine headaches, schizophrenia, depression, diarrheal illness, lower respiratory infection, malaria, bipolar disorder and HIV/AIDS.
While children account for 60 percent of the patients with these conditions, only 12 percent of the clinical drug trials involved children, the investigators found. The gap was widest for conditions that are widespread in low- and middle-income countries.
Clinical drug trials in children are important because youngsters often respond differently to medications than adults, the study authors pointed out in an American Academy of Pediatrics news release.
"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. Florence Bourgeois, an assistant professor at Harvard Medical School, said in the news release.
Lack of funding may be a major reason why there are so few clinical drug trials involving children, she noted.
"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," Bourgeois said.
She said additional programs and incentives are needed to increase the number of drugs tested in children.
"It is critical that drugs are studied that are most likely to benefit children, particularly children in developing countries who appear to be most neglected in the current research portfolio," Bourgeois said.
The study was slated for Saturday presentation at the Pediatric Academic Societies annual meeting, in Boston. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.
The U.S. Food and Drug Administration has more about children and clinical trials.
Posted: April 2012