{
  "abstract": "Background\n\nAdverse 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\n\nWe 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\n\nSubstantial 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.",
  "abstract_shown": true,
  "affiliations": [
    "Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.",
    "Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA."
  ],
  "article_type": "review article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Ryan Langerman"
    },
    {
      "affs": [
        0
      ],
      "name": "Graham N Jameison"
    },
    {
      "affs": [
        0
      ],
      "name": "Logan Corwin"
    },
    {
      "affs": [
        0
      ],
      "name": "Daniel Archer",
      "orcid": "0009-0000-9406-1653"
    },
    {
      "affs": [
        0
      ],
      "name": "Kellen Keefer"
    },
    {
      "affs": [
        0
      ],
      "name": "Rachel Hazlitt"
    },
    {
      "affs": [
        0
      ],
      "name": "Tag Harris",
      "orcid": "0009-0003-7979-5343"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Alicia Ito Ford",
      "orcid": "0000-0002-6866-2639"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Matt Vassar"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/56fc02yj6ts3r.bib",
  "cited_by": 0,
  "doi": "10.2147/clep.s608444",
  "fulltext_url": "https://europepmc.org/articles/PMC13726514",
  "id": "56fc02yj6ts3r",
  "issns": [
    "1179-1349"
  ],
  "landing_url": "https://europepmc.org/article/MED/42974145",
  "language": "eng",
  "licence": "CC-BY-NC",
  "licence_label": "CC BY-NC",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Review"
    ],
    [
      "openalex",
      "3004|Pharmaceutical industry and healthcare"
    ]
  ],
  "openalex": "W7224521083",
  "pdf_url": "https://europepmc.org/articles/PMC13726514?pdf=render",
  "pmcid": "PMC13726514",
  "pmid": "42974145",
  "published": "2026-10-29",
  "publisher": "Dove Press",
  "ris": "https://research.draconitic.com/paper/56fc02yj6ts3r.ris",
  "sources": [
    {
      "first_seen": "2026-11-04T15:20:47Z",
      "native_id": "MED:42974145",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42974145"
    },
    {
      "first_seen": "2026-11-05T12:22:50Z",
      "native_id": "PMC13726514",
      "source": "pmc",
      "url": "https://doi.org/10.2147/clep.s608444"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3004|Pharmaceutical industry and healthcare",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "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.",
  "title_text": "Discrepancies in Adverse Event Reporting Between ClinicalTrials.gov and Publications in HIV/AIDS Clinical Trials: A Pre-Post Analysis of the FDAAA Final Rule.",
  "type": "peer-reviewed",
  "updated_at": "2026-11-06T12:22:27Z",
  "url": "https://research.draconitic.com/paper/56fc02yj6ts3r",
  "venue": "Clinical epidemiology",
  "versions": []
}