Pediatric Academic Societies Annual Meeting

Pediatric Academic Societies Annual Meeting

Issue: June 2012
Perspective from Benjamin Ortiz, MD
Perspective from Ron Keren, MD, MPH
April 28, 2012
4 min read
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Children neglected in clinical drug trials

Issue: June 2012
Perspective from Benjamin Ortiz, MD
Perspective from Ron Keren, MD, MPH
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BOSTON — Compared with the number of industry-supported clinical drug trials conducted in adults, there are few trials being conducted in pediatric patients, according to a study presented here during the 2012 Pediatric Academic Societies Annual Meeting.

Nearly 60% of the disease burden for high-priority conditions is among children, yet only 12% of clinical drug trials are among pediatric patients, according to researchers from Harvard Medical School, who reported on the 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 identified all drug trials for the 10 highest burden conditions registered from 2006 to 2011 in ClinicalTrials.gov to measure how much research activity is devoted to conditions representing a high burden of pediatric disease. 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,” Bourgeois said during her presentation. “There is a need to strengthen the research agenda for common pediatric conditions, so it’s not just rare diseases that require more work. It is conditions that are common in children and that actually represent a high burden of disease in pediatrics.”

This discrepancy in pediatric vs. adult clinical trials was greatest for conditions prevalent in middle- and low-income countries, and Bourgeois suggested that the funding sources may play a part in the amount of research devoted to pediatric populations.

Session moderator Leo Transande, MD, MPP, who serves on the faculty in the department of pediatrics at New York University School of Medicine and also holds appointments in environmental medicine and at the Wagner School of Public Service, echoed the comments by Bourgeois.

“It’s embarrassing to see such a low rate of pediatric studies,” he said.

The investigators reported that 58.6% 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%, received industry funding.

Researchers also found differences between the designs of pediatric and adult trials. For example, studies conducted in adults were more likely to focus on safety outcomes and to be multicenter trials.

For more information:

Disclosure: Dr. Bourgeois reports no relevant financial disclosures.