Literature DB >> 30201741

How Do the Accrual Pattern and Follow-Up Duration Affect the Hazard Ratio Estimate When the Proportional Hazards Assumption Is Violated?

Miki Horiguchi1, Michael J Hassett2, Hajime Uno3,4.   

Abstract

In randomized clinical trials, the magnitude of the treatment effect is often reported using the hazard ratio (HR) even when the proportional hazards (PH) assumption is not met. Conducting numerical studies, this commentary illustrates how/why the HR estimate via the standard Cox's procedure is difficult to interpret even as an “average” treatment effect for non‐PH cases.

Keywords:  Clinical trials; Cox proportional hazards model; Survival data analysis; Time‐to‐event outcomes

Mesh:

Year:  2018        PMID: 30201741      PMCID: PMC6656438          DOI: 10.1634/theoncologist.2018-0141

Source DB:  PubMed          Journal:  Oncologist        ISSN: 1083-7159


  16 in total

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Authors:  Robert J Paridaens; Luc Y Dirix; Louk V Beex; Marianne Nooij; David A Cameron; Tanja Cufer; Martine J Piccart; Jan Bogaerts; Patrick Therasse
Journal:  J Clin Oncol       Date:  2008-09-15       Impact factor: 44.544

5.  On the restricted mean survival time curve in survival analysis.

Authors:  Lihui Zhao; Brian Claggett; Lu Tian; Hajime Uno; Marc A Pfeffer; Scott D Solomon; Lorenzo Trippa; L J Wei
Journal:  Biometrics       Date:  2015-08-24       Impact factor: 2.571

6.  Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies.

Authors:  Hajime Uno; Janet Wittes; Haoda Fu; Scott D Solomon; Brian Claggett; Lu Tian; Tianxi Cai; Marc A Pfeffer; Scott R Evans; Lee-Jen Wei
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Journal:  N Engl J Med       Date:  2015-09-27       Impact factor: 91.245

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9.  Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves.

Authors:  Patricia Guyot; A E Ades; Mario J N M Ouwens; Nicky J Welton
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10.  Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome.

Authors:  Patrick Royston; Mahesh K B Parmar
Journal:  BMC Med Res Methodol       Date:  2013-12-07       Impact factor: 4.615

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  4 in total

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3.  Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes.

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4.  Challenges of modelling approaches for network meta-analysis of time-to-event outcomes in the presence of non-proportional hazards to aid decision making: Application to a melanoma network.

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  4 in total

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