ArticleBMC medical research methodology2019
Two-stage optimal designs with survival endpoint when the follow-up time is restricted.
Article in BMC medical research methodology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Disease progression trajectory curves to estimate saved time in Alzheimer's disease trials.Contemporary clinical trials · 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
- 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
- Conservative confidence intervals for the intraclass correlation coefficient for clustered binary data.Journal of applied statistics · 2022Article
- Optimal two-stage designs based on restricted mean survival time for a single-arm study.Contemporary clinical trials communications · 2021Article
- Optimal two-stage design of single arm Phase II clinical trials based on median event time test.PloS one · 2021Article
- Two-stage optimal designs based on exact variance for a single-arm trial with survival endpoints.Journal of biopharmaceutical statistics · 2020Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
backgroundSurvival endpoint is frequently used in early phase clinical trials as the primary endpoint to assess the activity of a new treatment. Existing two-stage optimal designs with survival endpoint either over estimate the sample size or compute power outside the alternative hypothesis space.
methodsWe propose a new single-arm two-stage optimal design with survival endpoint by using the one-sample log rank test based on exact variance estimates. This proposed design with survival endpoint is analogous to Simon's two-stage design with binary endpoint, having restricted follow-up.
resultsWe compare the proposed design with the existing two-stage designs, including the two-stage design with survival endpoint based on the nonparametric Nelson-Aalen estimate, and Simon's two-stage designs with or without interim accrual. The new design always performs better than these competitors with regards to the expected total study length, and requires a smaller expected sample size than Simon's design with interim accrual.
conclusionsThe proposed two-stage minimax and optimal designs with survival endpoint are recommended for use in practice to shorten the study length of clinical trials.
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