May 1, 2012: Children are being overlooked for clinical drug trials for health conditions that typically impact them in high numbers (such as asthma): a preliminary study examining drug trials for the top 10 highest burden pediatric health problems found only 12% involved children, and in high-income countries, it drops to 10%.
Lead researcher Florence Bourgeois, MD, at left, pediatrics professor, Children's Hospital Boston, presented the preliminary findings at the Pediatrics Academic Societies annual meeting in Boston last weekend, reported on by Crystal Phend for Medpage Today, an online medical news source co-developed by The University of Pennsylvania School of Medicine.
The concern is that children's bodies absorb and distribute drugs at different rates and durations than adults, yet are prescribed them based on clinical trials that do not include pediatric participants; furthermore, pediatric trials were less likely to examine safety outcomes than adult trials (10% v. 17%).
"There is a deficiency in the amount of research activity not just for rare diseases, but also for diseases that are quite common among children, such as asthma," Bourgeois told MedPage Today.
Bourgeois' team identified all the drug trials registered from 2006-2011 with the National Institutes of Health's ClinicalTrials.gov, a database of federally and privately supported clinical trials conducted both in the United States and world-wide, for health conditions that impact children: asthma, migraine headache, schizophrenia, depression, diarrhea, lower respiratory infection, malaria, bipolar disorder, and HIV/AIDS.
Researchers found that funding for pediatric trials primarily comes from government or non-profit organization (60%), with little private funding from private industry (compared to 35% of adult trials).
When the researchers analyzed the trials by the type of country they were done in, they found even greater discrepancy for children in lower income nations.
In higher-income countries, children bore 21.4% of the disease burden for the conditions studied, but 9.8% of the clinical trials done for those conditions (P<0.001).
In middle- and low-income countries, children accounted for 61.9% of the disease burden, but just 11.9% of the trials (P<0.001).
"Given the current distribution of funding sources, we need more support from both nonprofit organizations as well as commercial entities or industry," Bourgeois said in an interview.
The Pediatrics Academic Societies meeting is jointly sponsored by the American Pediatric Society, the Society for Pediatric Research, the Academic Pediatric Association, and the American Academy of Pediatrics.
Written for California's Children by Elizabeth J Carlyle.