Nearly four dozen pediatric clinical trials involving more than 3,600 children failed to publish their findings on ClinicalTrials.gov or in scientific literature, according to a new analysis by U.K.-based trial transparency advocacy group TranspariMED and other non-U.S. researchers.

The analysis, posted on the preprint publication medRxiv, began in September 2022 and looked at 81 trials that were in violation of FDA reporting requirements, having neglected to upload results to CT.gov within a year of completion.

The researchers concluded that 43 pediatric trials within that group (encompassing 3,627 children) were completely unreported as of December 2022, despite the continued push by the FDA and other regulators for greater reporting compliance and enforcement of requirements.

Once again, transparency watchdogs are calling for the agency to step up its game and hold sponsors truly accountable for failing to be compliant.

“Our findings highlight the urgent need for FDA and the NIH to systematically enforce reporting requirements in order to curb research waste, reduce publication bias, and accelerate medical progress,” wrote Till Bruckner, founder of TranspariMED, and his coauthors.

The analysis was confined to trials exclusively involving patients who could be identified as U.S. children by registry data, meaning it left out trials lacking maximum participant age registry data and trials that aimed to enroll adults and children.

The FDA has been called out for failing to penalize noncompliant sponsors despite having this authority and to date has not issued a single fine. At the same time, it has received praise for its use of noncompliance letters, which have had success in pushing sponsors to share trial findings. It sent its first noncompliance letter in 2021 to Acceleron Pharma and has issued three more since then, according to the agency’s website (CenterWatch Weekly, May 3, 2021).

Access the preprint publication here: https://bit.ly/3WDNuqb.