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Patient accrual hampers completion of clinical trials, publication process
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Clinical trials involving children often remain unpublished or uncompleted despite new legislation encouraging such investigations, according to study findings in Pediatrics.
“Despite these heightened ethical and legislative mandates, the discontinuation and nonpublication of clinical trials remains common,” Florence Bourgeois, MD, MPH, associate physician in medicine, and Natalie Pica, MD, PhD, a resident, both at Boston Children’s Hospital, wrote. “Pediatric trials may be particularly vulnerable to these outcomes because they face unique challenges in terms of concerns around testing interventions in children and the logistics of recruiting and consenting research subjects in collaboration with parents and caretakers.”
In a comprehensive, retrospective, cross-sectional study that included government data of registered pediatric randomized clinical trials (RCTs) between 2008 and 2010, the researchers sought to determine the frequency of discontinuation and nonpublication for RCTs on children. Associated publications were identified and completed by a final search in September 2015.
Analysis showed that of the 559 pediatric RCTs conducted in the retrospective period, 19% were discontinued early, and these included more than 8,000 enrolled children. Of the 455 completed trials, which included more than 69,000 children, 29.8% remained unpublished after a mean of 58 months after trial completion. Reasons for discontinuation included difficulty accruing sufficient participants (36.5%) and trial conduct issues (12.5%), while funding was cited as the least likely reason to discontinue trials (4.8%).
There were 104 discontinued trials, and RCTs were less likely to be discontinued if they were funded by industry vs. an academic institution or private sponsor (OR = 0.46, 95% CI; 0.27-0.77). Also, trials sponsored by industry were less likely to be published than those sponsored by institutions. Results of a multivariate analysis showed that unpublished trials were more frequent for industry-sponsored trials 2 years after completion (OR = 2.21; 95% CI, 1.35-3.64) and 3 years after completion (OR = 3.12; 95% CI, 1.6-6.08).
“This is the first study to look systemically at discontinuation and nonpublication of interventional pediatric clinical trials,” Bourgeois said in a press release. “A number of legislative initiatives have been implemented to increase the study of interventions in children. Now we need to make sure that the proper resources are in place to ensure that information gleaned from these studies reaches the scientific community.” – by Kate Sherrer
Disclosure: The researchers report no relevant financial disclosures.
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