ArticleClinical trials (London, England)2021
Are restricted mean survival time methods especially useful for noninferiority trials?
Article in Clinical trials (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Non-inferiority and clinical superiority of glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors: Systematic analysis of cardiorenal outcome trials in type 2 diabetes.Diabetes, obesity & metabolism · 2022Pooled it
- A comparison of different population-level summary measures for randomised trials with time-to-event outcomes, with a focus on non-inferiority trials.Clinical trials (London, England) · 2023Trial
- Omitting axillary dissection in breast cancer patients with one to two positive sentinel nodes undergoing mastectomy: a retrospective and prospective cohort study with a target trial emulation.International journal of surgery (London, England) · 2026Article
- Power and sample size calculation for non-inferiority trials with treatment switching in intention-to-treat analysis comparing RMSTs.BMC medical research methodology · 2025Article
- Summary measures in non-inferiority clinical trials with a time-to-event outcome: an empirical comparison of power.BMC medical research methodology · 2025Article
- Using non-inferiority test of proportions in design of randomized non-inferiority trials with time-to-event endpoint with a focus on low-event-rate setting.Clinical trials (London, England) · 2025Article
- Pitfall in the Design and Analysis of Comparative Oncology Trials With a Time-to-Event Endpoint and Recommendations.JNCI cancer spectrum · 2022Article
- Why restricted mean survival time methods are especially useful for non-inferiority trials.Clinical trials (London, England) · 2021Article
- Reply to Quartagno et al.Clinical trials (London, England) · 2021Article
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Abstract
backgroundRestricted mean survival time methods compare the areas under the Kaplan-Meier curves up to a time
methodsThrough some limited simulations and asymptotic power calculations, the authors compare the operating characteristics of restricted mean survival time and proportional hazards methods for analyzing both noninferiority and superiority trials under proportional hazardss to understand what relative power benefits there are when using restricted mean survival time methods for noninferiority testing.
resultsIn the setting of low-event rates, very large targeted noninferiority margins, and limited follow-up past
conclusionAlthough there are special settings where restricted mean survival time methods have a power advantage over proportional hazards methods for testing noninferiority, the larger issue in these settings is defining appropriate noninferiority margins. We find the restricted mean survival time methods lacking in these regards.
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