Ed Silverman, Stat News, January 24, 2023
Amid ongoing controversy over clinical trial transparency, a new analysis found that results of 43 studies involving thousands of children were never reported to a U.S. government database or published in the scientific literature.
In some cases, medicines being studied were for such life-threatening conditions as congenital heart disease and Duchenne muscular dystrophy. One study explored the use of a particular painkiller for reducing the amount of opioids needed to treat pain following heart surgery. Another tested a drug for lowering aggression among children diagnosed with attention deficit hyperactivity disorder, or ADHD.
In each instance, the researchers scoured ClinicalTrials.gov, the federal database, and medical journals, but were unable to find results. More than 3,600 children participated across the 43 studies. There was partial information posted to the database or published in journals for another 22 studies, although the researchers noted that medical journal findings can be unreliable or omit relevant outcome data.
“When any adult or child participates in a clinical trial, they are taking a risk for the greater good, but if the results are not made public, those studies are of no help to anyone,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank that was one of three organizations that conducted the analysis. “Our next step is to work with Congress to fix this situation.”
The study has not yet been published in a scientific journal, but was made available on medRxiv, a preprint server. These platforms have become an increasingly popular destination for many studies before they have been peer-reviewed by medical journals.
In one instance, Astria Therapeutics failed to post results for an open label extension study of a drug to combat Duchenne muscular dystrophy. The study enrolled 130 boys. But after the Phase 3 trial failed, research into the drug was abandoned and the study was terminated. The company made the Phase 3 results available 110 days later than required by law.
But results for the extension study have still not been posted to ClinicalTrials.gov and are more than a year overdue. TranspariMED, another of the organizations that conducted the analysis, wrote that it was unable to locate final results from the extension study in scientific The company did not provide an explanation. We asked the company for an explanation and will update you accordingly.
In another instance, Phoenix Children’s Hospital ran a trial to determine whether a painkiller, ketorolac, could reduce opiates needed to treat pain in children after heart surgery. The hospital sought to enroll 166 infants and children aged between 3 months and 4 years. The primary completion date was December 2020, but results were never posted and the hospital did not respond to TranspariMED. We asked the hospital for comment and will pass along any reply.
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