Clinical trials in children commonly go either uncompleted or unpublished, according to a comprehensive study from HMS researchers at Boston Children’s Hospital. This perplexing news comes forward at the same time as recent legislation encouraging clinical trials in children, including the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
According to the study, published online August 4 in Pediatrics, 19 percent of trials were stopped early and results from 30 percent of completed trials remained unpublished in the medical literature several years later.
“We feel there is a lot of inefficiency and waste that could be addressed,” says senior investigator Florence Bourgeois, an HMS assistant professor of pediatrics at Boston Children’s.
Adds co-author Natalie Pica, an HMS clinical fellow in pediatrics at Boston Children’s, “Our findings are in line with previously published studies focusing on adult trials, which may speak to how commonplace discontinuation and nonpublication are in medical research in general.”
The researchers found that more than 8,000 children were enrolled in trials that were never completed and more than 69,000 children were enrolled in completed trials that were never published.
“We need to make sure that when children participate in clinical trials, their efforts are contributing to broader scientific knowledge,” says Pica.
Pica and Bourgeois tracked 559 randomized, controlled pediatric trials registered on ClinicalTrials.gov from 2008 to 2010 and whose status (completed or discontinued) was confirmed as final after December 31, 2012. They then searched for related peer-reviewed publications through September 1, 2015. When no publication could be found, they emailed study investigators and sponsors.
Overall, trials sponsored by industry were more likely to be completed than trials sponsored by academic institutions, the investigators found. However, completed trials sponsored by industry were less likely to be published than trials sponsored by academia and government. These findings are similar to those seen for clinical trials in adults.