Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials

Ariadna Tibau; Consolación Molto; Maria Borrell; Joseph C Del Paggio; Agustí Barnadas; Christopher M Booth; Eitan Amir

doi:10.1001/jamaoncol.2018.4300

Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials

JAMA Oncol. 2018 Nov 1;4(11):1610-1611. doi: 10.1001/jamaoncol.2018.4300.

Authors

Ariadna Tibau¹, Consolación Molto¹, Maria Borrell¹, Joseph C Del Paggio², Agustí Barnadas¹, Christopher M Booth^{3

4

5}, Eitan Amir²

Affiliations

¹ Department of Oncology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
² Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
³ Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, Ontario, Canada.
⁴ Department of Oncology, Queen's University, Kingston, Ontario, Canada.
⁵ Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada.

Abstract

This study uses the European Society of Medical Oncology Magnitude of Clinical Benefit Scale to evaluate the clinical benefit of anticancer drugs that gained approval by the US Food and Drug Administration based on single-arm rather than randomized clinical trials.

Publication types

Letter

MeSH terms

Antineoplastic Agents / pharmacology
Antineoplastic Agents / therapeutic use*
Drug Approval / methods*
Humans
United States
United States Food and Drug Administration

Substances

Antineoplastic Agents