A duo from Harvard Medical School reports that randomized controlled trials involving children are often discontinued and that, if they are completed, results from them don't always get published.
Harvard's Natalie Pica and Florence Bourgeois report in Pediatrics that they examined 559 randomized clinical trials conducted in a pediatric population that were registered at ClinicalTrials.gov between 2008 and 2010. Of those studies, 19 percent were stopped early, often due to difficulties in patient recruitment. In addition, of the completed studies, 30 percent were never published.
"That means all the participants who are enrolled in these studies aren't able to contribute in a meaningful way to our clinical information and knowledge," Bourgeois tells NPR. NPR adds that many parents enroll their children in trials with the expectation that they'll be helping medicine move ahead.
"When you do a clinical study and you're asking patients to participate and subject themselves to a risk, in order to inform science and generate knowledge — that you have an ethical obligation to disseminate those findings to the wider scientific community," adds Joseph Ross from the Yale School of Medicine. NPR notes that he has similar results as Bourgeois when he analyzed trials involving adults.
Pica and Bourgeois also note that the trial sponsor appears to influence whether a trial ends early or isn't published. Trials funded by academia were more likely to be discontinued, while trials funded by industry were more likely to go unpublished, the duo reports.