Treatment group-specific inferences in Phase III Randomized Oncology Trials
The majority of published phase III oncology trials present treatment group-specific inferences. However, this inference lacks statistical support, as patients are not randomly sampled from the underlying population, and conflicts with CONSORT guidelines. While ongoing methodological efforts to improve the transportability of treatment group-specific inferences are promising, conventional attempts to generalize treatment-specific outcomes from randomized trials may be misleading. Instead of inference, treatment group-specific outcomes should be described using measures of variability.
Authors
- 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)
- 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)
- Adina H. Passy (ORCID: https://orcid.org/0000-0002-8626-8969)
Institutions
- The University of Texas MD Anderson Cancer Center (US)
- Stanford University (US)
Publication Details
- Journal
- Acta Oncologica
- Published
- 2025-03-24
- DOI
- https://doi.org/10.2340/1651-226x.2025.42663
- Citations
- 2
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 5.26