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Statistics in Medicine
Article . 2025 . Peer-reviewed
License: CC BY
Data sources: Crossref
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PubMed Central
Article . 2025
License: CC BY
Data sources: PubMed Central
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https://dx.doi.org/10.48550/ar...
Article . 2024
License: arXiv Non-Exclusive Distribution
Data sources: Datacite
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Adaptive Weight Selection for Time‐To‐Event Data Under Non‐Proportional Hazards

Authors: Moritz Fabian Danzer; Ina Dormuth;

Adaptive Weight Selection for Time‐To‐Event Data Under Non‐Proportional Hazards

Abstract

ABSTRACTWhen planning a clinical trial for a time‐to‐event endpoint, we require an estimated effect size and need to consider the type of effect. Usually, an effect of proportional hazards is assumed with the hazard ratio as the corresponding effect measure. Thus, the standard procedure for survival data is generally based on a single‐stage log‐rank test. Knowing that the assumption of proportional hazards is often violated and sufficient knowledge to derive reasonable effect sizes is usually unavailable, such an approach is relatively rigid. We introduce a more flexible procedure by combining two methods designed to be more robust in case we have little to no prior knowledge. First, we employ a more flexible adaptive multi‐stage design instead of a single‐stage design. Second, we apply combination‐type tests in the first stage of our suggested procedure to benefit from their robustness under uncertainty about the deviation pattern. We can then use the data collected during this period to choose a more specific single‐weighted log‐rank test for the subsequent stages. In this step, we employ Royston‐Parmar spline models to extrapolate the survival curves to make a reasonable decision. Based on a real‐world data example, we show that our approach can save a trial that would otherwise end with an inconclusive result. Additionally, our simulation studies demonstrate a sufficient power performance while maintaining more flexibility.

Keywords

Methodology (stat.ME), FOS: Computer and information sciences, Clinical Trials as Topic, Models, Statistical, 62N03, Data Interpretation, Statistical, Methodology, Humans, Computer Simulation, Survival Analysis, Research Article, Proportional Hazards Models, G.3.16

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Average
Average
Green
hybrid