Pediatric Clinical Trial Results Often Not Reported or Published

Clinical trials are extremely important for pediatrics but conducting trials in children is more difficult due to ethical barriers, lack of funding and other issues. And, unfortunately, many of the pediatric clinical trials that do get initiated don’t finish or report out their results, according to a new study, “Early Discontinuation, Results Reporting, and Publication of Pediatric Clinical Trials,” in the April 2022 Pediatrics (published online March 22). Researchers found 11.1% of initiated trials were stopped early and about half (51.2%) that reached completion reported results or published. The study reports that these outcomes leave doctors and hospitals to rely on an incomplete and biased knowledge base, a well-described challenge in pediatrics, and waste limited resources for pediatric medical research. The study examined 13,259 clinical trials enrolling participants ages 18 and younger from October 2007 to March 2020 and found various reasons for research to be discontinued. Over a third stopped early due to poor participant accrual, which was the most common reason, but others were discontinued for staffing shortfalls. Government-funded trials and academic trials had lower odds of discontinuation compared to industry trials and were more likely to publish. Researchers concluded that, due to these important problems impacting the funding and integrity of pediatric medical research, targeted efforts are needed to support research completion and publication to support doctors.

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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.