Safety reporting in chronic kidney disease clinical trials: a comparison of ClinicalTrials.gov registries and published reports

Abstract

Transparent reporting of adverse events (AEs) is essential for evaluating the safety of interventions from chronic kidney disease (CKD), a population especially vulnerable to treatment-related harm because of polypharmacy, reduced renal clearance, and high comorbidity burden. Since 2007, the FDA Amendments Act (FDAAA 801) and its 2017 Final Rule have required applicable clinical trials to submit structured harms data to Clinical-Trials.gov [ 1 ]. Although discrepancies between registry and published harms data have been documented in other clinical domains, whether this registry information is faithfully reflected in the peer-reviewed literature for CKD trials specifically had not been examined [ 2 ]. We performed a cross-sectional registry–publication comparison of 142 CKD trials with results posted on ClinicalTrials.gov (2009–2024) and matched USA-based publications, drawn from 843 initially identified records. Two reviewers independently extracted AE data in duplicate, and reporting concordance was assessed descriptively, with Bland–Altman and funnel plots used to visualize agreement, and segmented regression used to evaluate change around the Final Rule’s 2017 implementation date. Serious adverse event (SAE) totals were consistent between ClinicalTrials.gov and the matched publication in only 11% of studies