ArticleStatistics in biopharmaceutical research2021
Statistical Considerations for Sequential Analysis of the Restricted Mean Survival Time for Randomized Clinical Trials.
Article in Statistics in biopharmaceutical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed.
- Two-Stage Double-Arm Trial Optimal Design of Restricted Mean Survival Time With Sculpted Critical Region.Statistics in medicine · 2026Article
- Sample Size Recalculation in Adaptive Group Sequential Study Designs for Comparing Restricted Mean Survival Times.Statistics in medicine · 2026Article
- Independent Increments and Group Sequential Tests.Statistics in medicine · 2025Article
- Biomarker-guided adaptive enrichment design with threshold detection for clinical trials with time-to-event outcome.Journal of biopharmaceutical statistics · 2025Article
- On Sample Size Determination for Augmented Tests Based on Restricted Mean Survival Time in Randomized Clinical Trials.Biometrical journal. Biometrische Zeitschrift · 2025Article
- Scaling and interpreting treatment effects in clinical trials using restricted mean survival time.Clinical trials (London, England) · 2025Article
- Simultaneous inference procedures for the comparison of multiple characteristics of two survival functions.Statistical methods in medical research · 2024Article
- Comparative Effectiveness and Safety of Seizure Prophylaxis Among Adults After Acute Ischemic Stroke.Stroke · 2023Article
- No short-term mortality from benzodiazepine use post-acute ischemic stroke after accounting for bias.Journal of clinical epidemiology · 2023Article
- Power and Sample Size Calculations for the Restricted Mean Time Analysis of Prioritized Composite Endpoints.Statistics in biopharmaceutical research · 2023Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
In this paper, we illustrate the method of designing a group-sequential randomized clinical trial based on the difference in restricted mean survival time (RMST). The procedure is based on theoretical formulations of Murray and Tsiatis (1999). We also present a numerical example in designing a cardiology surgical trial. Various practical considerations are discussed. R codes are provided in the Supplementary Materials. We conclude that the group-sequential design for RMST is a viable option in practice. A simulation study is performed to compare the proposed method to the Max-Combo and conventional log-rank tests. The simulation result shows that when there is a delayed treatment benefit and the proportional hazards assumption is untrue, the sequential design based on the RMST can be more efficient than that based on the log-rank test but less efficient than that based on the Max-Combo test. Compared with Max-Combo test, the RMST-based study design yield coherent estimand, statistical inference and result interpretation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.