A new study published in the journal Pediatrics finds that clinical trials involving over 69,000 children have never had their results published in a peer reviewed journal, and that the findings of nearly a hundred of these trials remain completely unknown. The study, authored by Natalie Pica and Florence Bourgeois, both from Harvard medical school, examined all 599 pediatric trials registered with Clinicaltrials.gov from 2008-2010 and found that 30% of completed trials remained unpublished. This is reportedly the first time researchers have specifically looked at the publication record of trials involving children.
The authors conclude that
thousands of children [were] exposed to interventions that did not lead to informative or published findings
Covering the study, Ivan Oransky and Adam Marcus of STAT warned that
by not publishing these studies, drug makers and scientists put young patients at risk, particularly if those data reveal dangerous side effects or other adverse events from taking medications
The study found that 19% of all paediatric trials, involving a total of 8,000 children, were discontinued early. Of the 455 completed trials, nearly a third were not published. Over 69,000 children took part in these 136 medical trials. Due to researchers’ failure to publish their findings in a journal, the medical discoveries made during trials are difficult for other researchers, doctors, and the parents of other ill kids to find.
Furthermore, the study reports that out of the 136 unpublished trials, only 42 had posted their results on ClinicalTrials.gov. The remaining 96 trials failed to do so, apparently in violation of the 2007 Food and Drug Administration Amendments Act. Thus, the research community, doctors and parents remain completely in the dark about the insights and discoveries generated by nearly a hundred clinical trials involving children.
Till Bruckner, campaign manager for AllTrials, commented that
This is yet another example of how clinical trial data is not being effectively shared with medical professionals and the public. Parents often allow their children to participate in these trials, despite the risks involved, to support the discovery of new treatments that could help other children with the same illness in the future. Testing new medicines in over 69,000 children and then neglecting to publish the results where others can easily find them is ethically indefensible.
STAT’s reporters reached a similar conclusion:
Of course, we know that some researchers will fight tooth and nail to keep their data private, choosing instead to build a wall and make the people asking for data to pay for it. But when even drug company titans see the benefits of putting it all out there, shouldn’t everyone?
The study, titled “Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children”, was published in the paywalled journal Pediatrics in August 2016.