Reporting of immune-related adverse events in US Food and Drug Administration approvals of immune checkpoint inhibitors
Our study demonstrated significant inconsistencies in irAE reporting in the primary literature of trials associated with FDA approvals, particularly for rarer irAEs. Efforts to standardize irAE reporting from clinical trials in the primary literature are needed for more consistent dissemination of information.
Authors
- Chongliang Luo (ORCID: https://orcid.org/0000-0003-3682-9454)
- Andrew A. Davis (ORCID: https://orcid.org/0000-0003-3663-2133)
- Vaibhav G. Patel (ORCID: https://orcid.org/0000-0003-2004-7298)
- Shaili Tapiavala
- Mina Shenouda (ORCID: https://orcid.org/0000-0003-2403-2739)
Institutions
- Washington University in St. Louis (US)
- Tisch Hospital (US)
Publication Details
- Journal
- Frontiers in Oncology
- Published
- 2025-08-13
- DOI
- https://doi.org/10.3389/fonc.2025.1606599
- Citations
- 2
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 2.09
Funders
- Washington University in St. Louis