Disclosures: Bourgeois reports no relevant financial disclosures. Please see the study for all authors’ relevant financial disclosures.
March 22, 2022
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Nearly half of pediatric trials do not publish or report results, study finds

Disclosures: Bourgeois reports no relevant financial disclosures. Please see the study for all authors’ relevant financial disclosures.
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Nearly half of pediatric clinical trials initiated over a more than 12-year period did not report or publish their results, according to a study published in Pediatrics.

Researchers conducted a cross-sectional analysis of 13,259 clinical trials that enrolled participants aged 18 years or younger from October 2007 to March 2020.

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Nearly half of all initiated pediatric clinical trials do not report results, according to a study in Pediatrics. Source: Adobe Stock

“The landscape of pediatric clinical trials, including drivers of completion and timely dissemination of results, is not well understood,” they wrote. “We aimed to characterize the prevalence of and factors associated with early discontinuation, results reporting, and publication of pediatric clinical trials.”

They found that 11.1% of the trials were stopped early, with recruitment failure noted as a predominant reason for discontinuation. Only around half (51.2%) reached completion, reported results or received publication.

Government-sponsored trials (adjusted OR = 0.72; 95% CI, 0.47-0.97) and academic trials (aOR = 0.64; 95% CI, 0.5-0.82) were less likely to be discontinued compared with industry trials. Government (aOR = 1.94; 95% CI, 1.52-2.48) and academic (aOR = 1.61; 95% CI, 1.35-1.92) trials also were more likely to be published than industry trials. The researchers also found that academic trial investigators were the least likely to report results (aOR = 0.34; 95% CI, 0.31-0.52).

“Although there are encouraging recent developments, challenges with the completion and timely reporting and publication of pediatric trial results persist,” the researchers wrote. “Our study outcomes are significantly associated with important trial characteristics, such as funding source. As the pediatric clinical trial ecosystem expands, so too must the mechanisms to address unique ethical, economic, and epidemiological barriers be prioritized.”

The study was accompanied by a commentary from Florence T. Bourgeois, MD, MPH, an associate professor of pediatrics at Harvard Medical School and director of the Pediatric Therapeutics and Regulatory Science Initiative at Boston Children’s Hospital.

“It is difficult to fully gauge the inefficiencies and loss this discontinuation rate represents without a better understanding of the resources invested in these trials or the number of participants enrolled in studies that failed to yield scientific findings,” Borgeois wrote. “Nonetheless, it provides a reference across a broad cohort of pediatric trials and confirms the ongoing challenge of recruiting pediatric participants to clinical trials.”

To act on the findings, the commentary says, researchers must build consensus on key features and trial outcomes “deemed essential to maximizing resources and advancing pediatric clinical care,” which could include measures of trial discontinuation, results reporting, and data sharing and reuse.

“Using a standard set of metrics, a data-driven approach could be applied to monitoring activities and directing modification and strengthening of research infrastructures, governing policies, and investment strategies,” Bourgeois wrote. “Formalizing ongoing evaluation would provide the needed tools to efficiently advance pediatric clinical trial infrastructures and maximize benefits to child health.”

References:

Bourgeois F, et al. Pediatrics. 2022; doi: 10.1542/peds.2021-055815.