Discrepancies in Adverse Event Reporting Between ClinicalTrials.gov and Publications in HIV/AIDS Clinical Trials: A Pre-Post Analysis of the FDAAA Final Rule.
- 1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
- 2Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Abstract
Background
Adverse event reporting is critical for interpreting and applying findings from HIV/AIDS clinical trials. Although registries such as ClinicalTrials.gov provide structured safety data, clinicians and guideline developers often rely primarily on peer-reviewed publications, which may selectively report harms. Prior research across multiple specialties has documented incomplete or inconsistent adverse event reporting in publications relative to registry entries, including incomplete reporting of serious harms. The consistency of adverse event reporting between registries and publications in HIV/AIDS trials has not been systematically evaluated.Main body
We conducted a registry-to-publication comparison study of interventional HIV/AIDS trials with results posted on ClinicalTrials.gov between September 27, 2009, and December 31, 2024. Corresponding publications were identified through ClinicalTrials.gov, PubMed, and Google Scholar. Eligible studies were Phase 2-4 (or not applicable), enrolled individuals living with HIV, evaluated therapeutic, preventive, or adherence-related interventions, and had both publicly posted registry results and a full-length English-language publication. Two independent reviewers extracted adverse event data using a standardized form. Outcomes included serious adverse events, other adverse events, treatment discontinuations, and mortality. Among 129 eligible trials, 62% showed mismatched serious adverse event counts between registry entries and publications, with registries more often reporting higher counts. An additional 28% of trials failed to report serious adverse event counts in either source - a distinct category of dual-source non-reporting. Across all reporting domains, registries more consistently reported complete safety data than publications. Following implementation of the 2017 Food and Drug Administration Amendments Act Final Rule, reporting improved within ClinicalTrials.gov (serious adverse events reported in 74% of trials) but remained low in publications (26%). Regression analyses demonstrated a significant increase in overall adverse event reporting completeness after the Final Rule (p < 0.001). Sponsor type was not associated with reporting completeness, whereas larger enrollment was associated with modestly lower completeness (p = 0.02).Conclusion
Substantial discrepancies persist between registry and publication reporting of adverse events in HIV/AIDS trials. Regulatory requirements were associated with changes in registry reporting patterns but did not eliminate inconsistencies in the published literature. Greater alignment between registry and journal reporting standards is needed to strengthen the transparency and reliability of safety evidence.
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BibTeX
@article{langerman2026discrepancies,
title = {{Discrepancies in Adverse Event Reporting Between ClinicalTrials.gov and Publications in HIV/AIDS Clinical Trials: A Pre-Post Analysis of the FDAAA Final Rule.}},
author = {Ryan Langerman and Graham N Jameison and Logan Corwin and Daniel Archer and Kellen Keefer and Rachel Hazlitt and Tag Harris and Alicia Ito Ford and Matt Vassar},
journal = {Clinical epidemiology},
year = {2026},
month = oct,
doi = {10.2147/clep.s608444},
url = {https://europepmc.org/article/MED/42974145},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Discrepancies in Adverse Event Reporting Between ClinicalTrials.gov and Publications in HIV/AIDS Clinical Trials: A Pre-Post Analysis of the FDAAA Final Rule.
AU - Ryan Langerman
AU - Graham N Jameison
AU - Logan Corwin
AU - Daniel Archer
AU - Kellen Keefer
AU - Rachel Hazlitt
AU - Tag Harris
AU - Alicia Ito Ford
AU - Matt Vassar
PY - 2026
DA - 2026/10/29
JO - Clinical epidemiology
DO - 10.2147/clep.s608444
UR - https://europepmc.org/article/MED/42974145
AB - Background Adverse event reporting is critical for interpreting and applying findings from HIV/AIDS clinical trials. Although registries such as ClinicalTrials.gov provide structured safety data, clinicians and guideline developers often rely primarily on peer-reviewed publications, which may selectively report harms. Prior research across multiple specialties has documented incomplete or inconsistent adverse event reporting in publications relative to registry entries, including incomplete reporting of serious harms. The consistency of adverse event reporting between registries and publications in HIV/AIDS trials has not been systematically evaluated.Main body We conducted a registry-to-publication comparison study of interventional HIV/AIDS trials with results posted on ClinicalTrials.gov between September 27, 2009, and December 31, 2024. Corresponding publications were identified through ClinicalTrials.gov, PubMed, and Google Scholar. Eligible studies were Phase 2-4 (or not applicable), enrolled individuals living with HIV, evaluated therapeutic, preventive, or adherence-related interventions, and had both publicly posted registry results and a full-length English-language publication. Two independent reviewers extracted adverse event data using a standardized form. Outcomes included serious adverse events, other adverse events, treatment discontinuations, and mortality. Among 129 eligible trials, 62% showed mismatched serious adverse event counts between registry entries and publications, with registries more often reporting higher counts. An additional 28% of trials failed to report serious adverse event counts in either source - a distinct category of dual-source non-reporting. Across all reporting domains, registries more consistently reported complete safety data than publications. Following implementation of the 2017 Food and Drug Administration Amendments Act Final Rule, reporting improved within ClinicalTrials.gov (serious adverse events reported in 74% of trials) but remained low in publications (26%). Regression analyses demonstrated a significant increase in overall adverse event reporting completeness after the Final Rule (p < 0.001). Sponsor type was not associated with reporting completeness, whereas larger enrollment was associated with modestly lower completeness (p = 0.02).Conclusion Substantial discrepancies persist between registry and publication reporting of adverse events in HIV/AIDS trials. Regulatory requirements were associated with changes in registry reporting patterns but did not eliminate inconsistencies in the published literature. Greater alignment between registry and journal reporting standards is needed to strengthen the transparency and reliability of safety evidence.
SN - 1179-1349
ER -