This article is more than 5 years old. Information may no longer be current.
Medication trials in children less common than adult trials
Children comprise the majority of disease burden, but it is a still a struggle to get clinical trials in this vulnerable age group, according to results of a recently published study.
Florence T. Bourgeois, MD, MPH, of Children’s Hospital in Boston, and colleagues looked at all of the trials registered with ClinicalTrials.gov between 2006 and 2011 and then reported details on the trials for conditions that primarily affect children.
About 60% of the disease burden was seen in children, but only 12% of the 2,440 trials were in the pediatric age group, according to the researchers. Bourgeois and colleagues also said randomized trials were less likely to look at safety outcomes in pediatric populations when compared with adult trials.
Bourgeois and colleagues said the disproportionate amount of adult trials may be because enrollment procedures are more complicated in pediatric trials, and there is a smaller market share and return on investment in pediatric medications.
They also said pharmaceutical companies funded most of adult trials, but pediatric trials were funded primarily by government and nonprofit organizations, and those budgets for clinical trials are currently limited.
“Our findings serve as a benchmark for the current state of pediatric drug research and indicate that further efforts are needed to increase the amount of clinical evidence available to guide physicians in the optimal use of pharmaceuticals in children,” Bourgeois told Infectious Diseases in Children. “Evidence is lacking not just for rare diseases, but for conditions that represent very high burdens of disease in children.”
Disclosure: Dr. Bourgeois reports no relevant financial disclosures.
