Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group
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TLDR
In this article, a log-rank test was used to evaluate the risk of nonproportional hazard in a clinical trial where NPH is a possibility and loss of power and clear description of treatment differences are key issues in designing and analyzing clinical trials.Abstract:
Loss of power and clear description of treatment differences are key issues in designing and analyzing a clinical trial where nonproportional hazard (NPH) is a possibility. A log-rank test may be i...read more
Citations
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Journal ArticleDOI
Alternative Analysis Methods for Time to Event Endpoints Under Nonproportional Hazards: A Comparative Analysis
Ray S. Lin,Ji Lin,Satrajit Roychoudhury,Keaven M. Anderson,Tianle Hu,Bo Huang,Larry Leon,Jason J. Z. Liao,Rong Liu,Xiaodong Luo,Pralay Mukhopadhyay,Rui Qin,Kay Tatsuoka,Xuejing Wang,Yang Wang,Jian Zhu,Tai-Tsang Chen,Renee Iacona +17 more
TL;DR: The log-rank test is most powerful under proportional hazards (PH) as mentioned in this paper, however, non-PH patterns are often observed in clinical trials, such as in immuno-oncology; therefore, alternative methods ar...
Journal ArticleDOI
K-sample omnibus non-proportional hazards tests based on right-censored data:
TL;DR: In this paper, the authors present novel and powerful tests for comparing non-proportional hazard functions, based on sample-space partitions, with right censoring, which makes the exis...
Journal ArticleDOI
Rejoinder to Letter to the Editor "The Hazards of Period Specific and Weighted Hazard Ratios".
Ray S. Lin,Ji Lin,Satrajit Roychoudhury,Keaven M. Anderson,Tianle Hu,Bo Huang,Larry Leon,Jason J. Z. Liao,Rong Liu,Xiaodong Luo,Pralay Mukhopadhyay,Rui Qin,Kay Tatsuoka,Xuejing Wang,Yang Wang,Jian Zhu,Tai-Tsang Chen,Renee Iacona +17 more
TL;DR: This document would like to thank the authors of the letter (Bartlett et al. 2020) for sharing their concerns regarding reporting treatment effect under nonproportional hazards (NPH), and they respect their views.
Posted Content
Non-proportional hazards in immuno-oncology: is an old perspective needed?
TL;DR: A fundamental concept in two-arm non-parametric survival analysis is the comparison of observed versus expected numbers of events on one of the treatment arms (the choice of which arm is arbitrary), where the expectation is taken assuming that the true survival curves in the two arms are identical.
Journal ArticleDOI
Assessing Treatment Benefit in Immuno-oncology
TL;DR: Adaptations to tumor response and progression criteria for immune therapies are reviewed, and generalized pairwise comparisons offer much promise in the field of immuno-oncology, both to detect late emerging treatment effects and as a general approach to personalize treatment choices through a benefit/risk approach.
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