There is a promising trend toward a decrease in publication bias and nonpublication rates of randomized clinical trials in pediatric research, according to the results of a study published in JAMA Network Open.
Publication bias, or the publication of primarily positive studies, compromises scientific research and constitutes a threat to evidence-based medicine. The authors suggest that publication bias may be an even greater problem in pediatric populations because of the challenges of conducting controlled clinical trials in children.
Leah K. Crockett, MSc, from the George and Fay Yee Centre for Healthcare Innovation Winnipeg, Manitoba, Canada, and colleagues conducted a cohort study, screening abstracts accepted by Pediatric Academic Societies meetings from May 2008 to May 2011 to identify phase 3 randomized clinical trials that enrolled pediatric populations. Investigators then searched electronic databases to determine whether or not these studies had been published. They measured study internal validity using the Cochrane Risk of Bias Tool, the Jadad scale, and allocation concealment. They examined associations between key variables, such as trial design and study stage, and publication status, time to publication, and publication bias.
Of a total of 177,787 abstracts identified in the Pediatric Academic Societies database, 3132 were clinical trials, and 129 met eligibility criteria. Of those, 72.1% were subsequently published. These results were then compared with those of a previous analysis. Fewer studies in the current analysis remained unpublished (27.9%) than in the previous analysis (40.9%; odds ratio [OR], 0.56; P =.008). Factors significantly associated with publication included larger sample size (OR, 1.92; P =.01) and registration on ClinicalTrials.gov (OR, 13.54; P <.001). The authors found no difference between published and unpublished trials in quality measures, risk for bias, or preference for positive results (OR, 1.60; P =.34), nor did they observe a difference in time to publication between studies with significant vs nonsignificant findings (25.61 vs 26.86 months; P =.93).
Although this trend is encouraging, the authors note that results of 3 of 10 pediatric studies still go unpublished. In this sample of studies, that translates into 4192 children who received an intervention while participating in a trial in which the findings did not contribute to the evidence base. The authors call for enforcement of mandatory trial registration and publication of all trials, particularly pediatric trials.
Crockett LK, Okoli GN, Neilson CJ, Rabbani R, Abou-Setta AM, Klassen TP. Publication of randomized clinical trials in pediatric research. A follow-up study. JAMA Network Open. 2018;1(1):e180156. doi: 10.1001/jamanetworkopen.2018.0156