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Children Usually Excluded From Clinical Drug Trials: Study

Children Usually Excluded From Clinical Drug Trials: Study

04/30/12

MONDAY, April 30 (HealthDay News) -- 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.

More information

The U.S. Food and Drug Administration has more about children and clinical trials.

Copyright © 2012 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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