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

A typical biosimilar study in oncology uses the overall response evaluated at a specific time point as the primary endpoint, which is generally acceptable regulatorily, to assess clinical equivalence between a biosimilar and its reference product. The standard primary endpoint for evaluating an anti...

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Autores principales: Uno, Hajime, Schrag, Deborah, Kim, Dae Hyun, Tang, Dejun, Tian, Lu, Rugo, Hope S, Wei, Lee-Jen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050006/
https://www.ncbi.nlm.nih.gov/pubmed/32337484
http://dx.doi.org/10.1093/jncics/pkz058
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author Uno, Hajime
Schrag, Deborah
Kim, Dae Hyun
Tang, Dejun
Tian, Lu
Rugo, Hope S
Wei, Lee-Jen
author_facet Uno, Hajime
Schrag, Deborah
Kim, Dae Hyun
Tang, Dejun
Tian, Lu
Rugo, Hope S
Wei, Lee-Jen
author_sort Uno, Hajime
collection PubMed
description A typical biosimilar study in oncology uses the overall response evaluated at a specific time point as the primary endpoint, which is generally acceptable regulatorily, to assess clinical equivalence between a biosimilar and its reference product. The standard primary endpoint for evaluating an anticancer therapy, progression-free or overall survival would be a secondary endpoint in a biosimilar trial. With a conventional analytic procedure via, for example, hazard ratio to quantify the group difference, it is difficult and challenging to assess clinical equivalence with respect to progression-free or overall survival because the study generally has a limited number of clinical events observed in the study. In this article, we show that an alternative procedure based on the restricted mean survival time, which has been discussed extensively for design and analysis of a general equivalence study, is readily applicable to a biosimilar trial. Unlike the hazard ratio, this procedure provides a clinically interpretable estimate for assessing equivalence. Using the restricted mean survival time as a summary measure of the survival curve will enhance better treatment decision making in adopting a biosimilar product over the reference product.
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spelling pubmed-70500062020-04-24 Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes Uno, Hajime Schrag, Deborah Kim, Dae Hyun Tang, Dejun Tian, Lu Rugo, Hope S Wei, Lee-Jen JNCI Cancer Spectr Commentary A typical biosimilar study in oncology uses the overall response evaluated at a specific time point as the primary endpoint, which is generally acceptable regulatorily, to assess clinical equivalence between a biosimilar and its reference product. The standard primary endpoint for evaluating an anticancer therapy, progression-free or overall survival would be a secondary endpoint in a biosimilar trial. With a conventional analytic procedure via, for example, hazard ratio to quantify the group difference, it is difficult and challenging to assess clinical equivalence with respect to progression-free or overall survival because the study generally has a limited number of clinical events observed in the study. In this article, we show that an alternative procedure based on the restricted mean survival time, which has been discussed extensively for design and analysis of a general equivalence study, is readily applicable to a biosimilar trial. Unlike the hazard ratio, this procedure provides a clinically interpretable estimate for assessing equivalence. Using the restricted mean survival time as a summary measure of the survival curve will enhance better treatment decision making in adopting a biosimilar product over the reference product. Oxford University Press 2019-08-01 /pmc/articles/PMC7050006/ /pubmed/32337484 http://dx.doi.org/10.1093/jncics/pkz058 Text en © The Author(s) 2019. Published by Oxford University Press. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contactjournals.permissions@oup.com.
spellingShingle Commentary
Uno, Hajime
Schrag, Deborah
Kim, Dae Hyun
Tang, Dejun
Tian, Lu
Rugo, Hope S
Wei, Lee-Jen
Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
title Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
title_full Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
title_fullStr Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
title_full_unstemmed Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
title_short Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
title_sort assessing clinical equivalence in oncology biosimilar trials with time-to-event outcomes
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050006/
https://www.ncbi.nlm.nih.gov/pubmed/32337484
http://dx.doi.org/10.1093/jncics/pkz058
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