Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study

Abstract

Background Incomplete and inconsistent reporting of adverse events (AEs) through multiple sources can distort impressions of the overall safety of the medical interventions examined as well as the benefit-risk relationship. We aimed to assess completed allergic rhinitis (AR) trials registered in ClinicalTrials.gov for completeness and consistency of AEs reporting comparing ClinicalTrials.gov and corresponding publications. Methods We retrospectively examined completed randomised controlled trials on AR registered in ClinicalTrials.gov on or after 9/27/2009 to trials updated with results on or before 12/31/2021 along with any corresponding publications. Complete reporting of AEs in ClinicalTrials.gov were summarised in tables describing AE information, and complete reporting in publications was an explicit statement of serious AE, death or other AE. Difference in completeness, number, or description of AEs between ClinicalTrials.gov and publication was classified as inconsistent reporting of AEs. Results There were 99 registered trials with 45 (45.5%) available publications. All published trials completely reported AEs in ClinicalTrials.gov, and 21 (46.7%) in publications (P < .001). In 43 (95.6%) publications, there was at least one inconsistency in the reporting of AEs (P < .001). 8 (17.8%) publications had different number of serious AEs (P = .003), 36 (80.0%) of other AEs (P < .001) while deaths reporting was inconsistent in 8 (57.1%) publications (P = .127). Conclusion The reporting of AEs from AR trials is complete in ClinicalTrials.gov and incomplete and inconsistent in corresponding publications. There is a need to improve the reporting of AEs from AR trials in corresponding publications, and thus to improve patient safety.

Publication status and disclosure gaps in a cohort of 71 clinical trials assessing the safety and efficacy of 3 COVID-19 vaccines developed by Chinese biopharmaceutical companies: An observational cohort study

“…This approach improves the findability of trial outcomes. However, it fails to realise two other key advantages of registry reporting in tabular summary results format compared to journal publication: accelerated reporting timelines, and improved completeness and accuracy of outcome data (20)(21)(22)(23)(24)(25). Thus, while between 2/49 (4%) of trials (Scenario 1) and 2/71 (3%) of trials (Scenario 2) technically met WHO best practices in clinical trial reporting, no trial fully delivered on the benefits of registry reporting.…”

Reporting characteristics of nonsurgical periodontal therapy trials registered in ClinicalTrials.gov: an observational study

“…The finding of discrepancies between important aspects of clinical trials involving NSPP, including primary outcomes, in the trial registry and related journal articles points to low transparency and questionable validity of the trials, creating problems in adequate introduction of tested interventions in clinical practice. While the registration mandate by journals, followed by legislative mandates, has greatly increased the transparency of trial protocol information [ 33 , 34 ], the problem of trial registration quality persists, not only in dental medicine, as demonstrated in our study, but in other clinical disciplines [ 35 , 36 ].…”