Almost half of pediatric clinical trials are either never finished or go unpublished, according to a new study published in the journal Pediatrics.
Researchers examined data on 559 pediatric trials registered on ClinicalTrials.gov from 2008 to 2010. The trials selected either had a final status of completed or discontinued by 2012. Researchers then searched for peer-reviewed studies published through Sept. 1, 2015. When the researchers could not find a published article to correspond with a registered study, they reached out to the study's sponsors and researchers for further information.
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Investigation revealed that 19 percent of the trials had been discontinued prematurely — two-thirds of these cases had already enrolled participants. Post-completion, 30 percent of the studies remained unpublished after nearly five years. Trials sponsored by industry were more likely to be completed than those backed by academic institutions, but trials supported by academia were more likely to published after completion than those sponsored by industry. In total, 8,000 children were enrolled in unfinished trials and more than 69,000 children participated in completed trials that were never published.
"This is the first study to look systematically at discontinuation and nonpublication of interventional pediatric clinical trials," said senior investigator Florence Bourgeois, MD, of Boston Children's Hospital. "A number of legislative initiatives have been implemented to increase the study of interventions in children. Now we need to make sure that the proper resources are in place to ensure that information gleaned from these studies reaches the scientific community."
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