Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study
Although most published noninferiority and equivalence trials have clear justification for their design, few provide rationale for the chosen margin or report a per-protocol analysis. These findings underscore the need for rigorous standards in trial design and reporting.
Authors
- Andrew Arifin (ORCID: https://orcid.org/0000-0002-4458-9983)
- Timothy A. Lin (ORCID: https://orcid.org/0000-0003-4183-9120)
- Alexander D. Sherry (ORCID: https://orcid.org/0000-0001-5115-1691)
- Ethan B. Ludmir (ORCID: https://orcid.org/0000-0002-5472-5344)
- Zachary R. McCaw (ORCID: https://orcid.org/0000-0002-2006-9828)
- T. Kleber (ORCID: https://orcid.org/0000-0003-3832-8274)
- Joseph Abi Jaoude (ORCID: https://orcid.org/0000-0002-2283-4765)
- Ramez Kouzy (ORCID: https://orcid.org/0000-0002-1521-0495)
- Pavlos Msaouel (ORCID: https://orcid.org/0000-0001-6505-8308)
- Esther J. Beck
- Gabrielle S. Kupferman (ORCID: https://orcid.org/0000-0003-2088-4395)
- Adina H. Passy (ORCID: https://orcid.org/0000-0002-8626-8969)
- Avital M Miller
Institutions
- University of North Carolina at Chapel Hill (US)
- Western University (CA)
- The University of Texas MD Anderson Cancer Center (US)
- Johns Hopkins University (US)
- Johns Hopkins Medicine (US)
- London Health Sciences Centre (CA)
- International Neuromodulation Society (US)
- Stanford University (US)
Publication Details
- Journal
- JNCI Journal of the National Cancer Institute
- Published
- 2024-12-06
- DOI
- https://doi.org/10.1093/jnci/djae318
- Citations
- 2
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 1.42
Funders
- Andrew Sabin Family Foundation
- National Institutes of Health
- University of Texas MD Anderson Cancer Center
- National Cancer Institute