ArticleContemporary clinical trials communications2021
Optimal two-stage designs based on restricted mean survival time for a single-arm study.
Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Two-Stage Double-Arm Trial Optimal Design of Restricted Mean Survival Time With Sculpted Critical Region.Statistics in medicine · 2026Article
- Disease progression trajectory curves to estimate saved time in Alzheimer's disease trials.Contemporary clinical trials · 2025Article
- Blood biomarkers as surrogate endpoints in Alzheimer's disease research.Frontiers in aging neuroscience · 2025Article
- Sample size calculation for the sequential parallel comparison design with binary endpoint using exact methods.Journal of applied statistics · 2025Article
- Continuity corrected score confidence interval for the difference in proportions in paired data.Journal of applied statistics · 2024Article
- Response adaptive randomization design for a two-stage study with binary response.Journal of biopharmaceutical statistics · 2023Article
- Continuity corrected Wilson interval for the difference of two independent proportions.Journal of statistical theory and applications : JSTA · 2023Article
- New Confidence Intervals for Relative Risk of Two Correlated Proportions.Statistics in biosciences · 2023Article
- Effects of dose change on the success of clinical trials.Contemporary clinical trials communications · 2022Article
- Monte Carlo cross-validation for a study with binary outcome and limited sample size.BMC medical informatics and decision making · 2022Article
- Randomized two-stage optimal design for interval-censored data.Journal of biopharmaceutical statistics · 2022Article
- Conservative confidence intervals for the intraclass correlation coefficient for clustered binary data.Journal of applied statistics · 2022Article
- Machine learning methods to predict amyloid positivity using domain scores from cognitive tests.Scientific reports · 2021Article
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Authors and funding
1 author.
Funding
Abstract
Restricted mean survival time is an alternative measure of treatment effect to hazard ratio in clinical trials with time-to-event outcome. The current methods have been focused on one-stage designs. In this article, we propose optimal two-stage designs for a single-arm study with the smallest expected sample size. We compare the performance of the new optimal two-stage designs with the existing one-stage design with regards to the expected sample size and the expected total study length. The simulation results indicate that the new two-stage designs can save the expected sample size substantially as compared to the one-stage design. We use a non-small cell lung cancer trial to illustrate the application of the proposed designs. The proposed optimal two-stage designs are recommended for use when time for patient accrual is longer than the pre-specified follow-up time.
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