What question did this study set out to answer?

To systematically identify and synthesize statistical methods and software designed to analyze time-to-event data when the proportional hazards assumption is violated in clinical trials.

April 9, 2024Statistical Methods in Medical ResearchOpen Access

Methods for non-proportional hazards in clinical trials: A systematic review

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Authors

MBMaximilian BardoUniversitätsmedizin Göttingen CHCynthia HuberUniversitätsmedizin Göttingen NBNorbert BendaFederal Institute for Drugs and Medical Devices

Discussion

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Implication

Systematic review uncovers diverse statistical strategies for non-proportional hazards in clinical trials, highlighting tailored testing and sample size methods.

Key Points

To systematically identify and synthesize statistical methods and software designed to analyze time-to-event data when the proportional hazards assumption is violated in clinical trials.
Conducted a systematic literature search across bibliographic databases to identify statistical methods, software implementations, and applications addressing non-proportional hazards.
Screened 907 citations and included 211 eligible articles for full-text review and methodological synthesis.
The 211 included publications were predominantly methodological papers, whereas review articles and applied clinical studies were relatively uncommon.
Identified strategies encompassed effect measures, regression approaches, hypothesis testing frameworks, and sample size calculations tailored to specific non-proportional hazard patterns.

Cite This Study

Bardo et al. (2024) studied this question.

synapsesocial.com/papers/6a734e67fa00d98af8562866 https://doi.org/10.1177/09622802241242325

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Implication

Systematic review uncovers diverse statistical strategies for non-proportional hazards in clinical trials, highlighting tailored testing and sample size methods.

Methods for non-proportional hazards in clinical trials: A systematic review

Discussion

Member takes

Implication

Key Points

Cite This Study

Methods for non-proportional hazards in clinical trials: A systematic review

Discussion

Member takes

Implication

Key Points

Cite This Study

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