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

SUBMITTER: Paladin I 

PROVIDER: S-EPMC9533497 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature