Publication of Randomized Clinical Trials in Pediatric Research: A Follow-up Study

Nonpublication of research results in considerable research waste and compromises medical evidence and the safety of interventions in child health. To replicate, compare, and contrast the findings of a study conducted 15 years ago to determine the impact of ethical, editorial, and legislative mandates to register and publish findings. In this cohort study, abstracts accepted to the Pediatric Academic Societies (PAS) meetings from May 2008 to May 2011 were screened in duplicate to identify phase 3 randomized clinical trials enrolling pediatric populations. Subsequent publication was ascertained through a search of electronic databases in 2017. Study internal validity was measured using the Cochrane Risk of Bias Tool, the Jadad scale, and allocation concealment, and key variables (eg, trial design and study stage) were extracted. Associations between variables and publication status, time to publication, and publication bias were examined. Publication rate, trial registration rate, study quality, and risk of bias. A total of 177 787 abstracts were indexed in the PAS database. Of these, 3132 were clinical trials, and 129 met eligibility criteria. Of these, 93 (72.1%; 95% CI, 53.8%-79.1%) were published. Compared with the previous analysis, the current analysis showed that fewer studies remained unpublished (183 of 447 [40.9%] vs 36 of 129 [27.9%], respectively; odds ratio [OR], 0.56; 95% CI, 0.36-0.86; P = .008). Fifty-one of 129 abstracts (39.5%) were never registered. Abstracts with larger sample sizes (OR, 1.92; 95% CI, 1.15-3.18; P = .01) and those registered in ClinicalTrials.gov (OR, 13.54; 95% CI, 4.78-38.46; P