Where are the results for these 2,272 clinical trials involving children?
A staggering 2,272 clinical trials involving children had not made their results public within three years of trial completion, a new study shows.
In total, results could not be found for nearly half (48%) of all pediatric trials, following a search of both trial registries and academic journals.
According to the authors:
“Clinical trial investigators who… fail to disseminate results compromise the integrity of evidence-based medicine and waste limited resources. These outcomes lead clinical guideline authors, policymakers, and funding authorities to rely on an incomplete and biased knowledge base, a well-described challenge in pediatrics.”
Academic trials (45%) involving children were far less likely to make their results public within three years than trials sponsored by government (59%) or industry (61%).
The study also shows that after the three year mark has passed, only few additional trial results are made public.
Till Bruckner, founder of TranspariMED, said:
“This study throws a stark light onto three scandals at once. The first scandal is that thousands of clinical trial results are never made public, betraying patients’ trust and leaving dangerous gaps in the medical evidence base.
“The second scandal is that many sponsors seem to feel no urgency in making their trial results public. Why was it so urgent to immediately make all Covid vaccine trial results public, but not the results of trials involving terminally ill children with cancer?”
“The third and arguably worst scandal is that all of this is either legal, or in cases where it is not, the National Institutes of Health and the FDA are turning a blind eye.”
According to World Health Organisation best practices, the results of all clinical trials should be made public on a trial registry within 12 months of trial completion. In the case of pediatric investigative drug trials run in the European Union, the reporting timeframe is just 6 months.
The ClinicalTrials.gov registry enables researchers to rapidly make results public without compromising their ability to later publish the same results in a medical journal.
The study examined a total of 4,657 pediatric trials registered on the American trial registry ClinicalTrials.gov from October 2007 that had been completed by March 2017. Of these, 24% had reported results to the ClinicalTrials.gov registry, and 39% had published results in a peer-reviewed journal, within three years of trial completion.
The study included all interventional pediatric trials, including trials run abroad by non-US sponsors. It excluded trials that involved both children and adults. It also discusses discontinued trials and contains a wealth of further data.