The US Food and Drug Administration's use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation

Ann Oncol. 2018 Mar 1;29(3):527-529. doi: 10.1093/annonc/mdy008.

Authors

E P DeLoughery¹, V Prasad²

Affiliations

¹ Mayo Clinic School of Medicine, Rochester, USA.
² Division of Hematology and Medical Oncology, Knight Cancer Institute, Portland, USA; Department of Preventive Medicine and Public Health, Oregon Health and Science University, Portland, USA; Center for Health Care Ethics, Oregon Health and Science University, Portland, USA. Electronic address: prasad@ohsu.edu.

PMID: 29346605
DOI: 10.1093/annonc/mdy008

No abstract available

Publication types

Editorial

MeSH terms

Antineoplastic Agents / therapeutic use*
Clinical Trials as Topic / methods*
Clinical Trials as Topic / standards
Drug Approval / legislation & jurisprudence
Drug Approval / methods*
Humans
United States
United States Food and Drug Administration / legislation & jurisprudence
United States Food and Drug Administration / standards*

Substances

Antineoplastic Agents