Performance of Control Arms in Trials Leading to FDA Cancer Drug Approvals
The PFS benefit observed in several trials leading to FDA approval of new anticancer drugs may have been influenced by shorter-than-expected PFS in the control arms. Accurate analysis of control-arm outcomes in clinical trials is therefore essential to ensure an accurate and comprehensive assessment of the efficacy of experimental therapies.
Authors
- Lucia Longo (ORCID: https://orcid.org/0000-0003-4805-6241)
- Angela Viggiano
- F. Salomone
- Luigi Liguori (ORCID: https://orcid.org/0000-0002-0232-1452)
- R. Bianco
- Felice Pepe (ORCID: https://orcid.org/0000-0001-6507-9993)
- M. Isernia
- Giuseppe Viscardi (ORCID: https://orcid.org/0000-0003-4473-9387)
- Marina Gilli
- Alberto Servetto (ORCID: https://orcid.org/0000-0003-3624-224X)
- Fabiana Vitiello (ORCID: https://orcid.org/0009-0007-2984-4257)
- L. Formisano
- Anna Russo (ORCID: https://orcid.org/0000-0002-0533-3053)
- Filippo Vitale
- Annarita Avanzo (ORCID: https://orcid.org/0009-0001-9249-8699)
- Antonio Santaniello
- Simeone D’Ambrosio
- Fabiana Napolitano
Institutions
- University of Salerno (IT)
- Ospedale Monaldi (IT)
- University of Naples Federico II (IT)
- The University of Texas Southwestern Medical Center (US)
Publication Details
- Journal
- Journal of the National Comprehensive Cancer Network
- Published
- 2025-12-22
- DOI
- https://doi.org/10.6004/jnccn.2025.7093
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00