Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs | Zendy

Bishal Gyawali | Zendy; Frazer A. Tessema | Zendy; Emily H. Jung | Zendy; Aaron S. Kesselheim | Zendy

Open Access

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs

Author(s) -

Bishal Gyawali,

Frazer A. Tessema,

Emily H. Jung,

Aaron S. Kesselheim

Publication year - 2019

Publication title -

jama network open

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.278

H-Index - 39

ISSN - 2574-3805

DOI - 10.1001/jamanetworkopen.2019.9570

Subject(s) - medicine , hazard ratio , randomized controlled trial , clinical trial , confidence interval , meta analysis , clinical endpoint , oncology

Key Points Question Is the source of funding associated with the justification for using noninferiority design and success in claiming noninferiority in cancer drug trials, and are these trials associated with changes in patient survival? Findings In this systematic review and pooled analysis of 23 randomized noninferiority trials of cancer drugs, which used overall survival as the end point and enrolled 21 437 patients, industry funding was associated with lack of justification but not with success in achieving noninferiority. No association of noninferiority trials with patient survival was found. Meaning Greater regulatory attention should be paid to randomized noninferiority trials of cancer drugs, especially regarding the justification for using such a design.

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