WebbSimon’s two-stage designs are popular single-arm, binary-endpoint clinical trials that include a single interim analysis for futility. In the literature, it is widely acknowledged that the inferential statistics calculated (p-values, point estimates, and confidence limits) in Simon’s designs typically do not account WebbMethods and analysis BUTEO is a single-arm, two-stage, open-label, multi-centre, phase II clinical trial. Up to 59 patients will receive treatment with anti-VAP monoclonal antibody, BTT1023, over a 78-day treatment period. Adults with PSC and a serum alkaline phosphatase (ALP) of at least 1.5 times the upper limit of normal will be included.
simon二阶段设计样本量计算 - 知乎 - 知乎专栏
Webb11 feb. 2024 · Simon är inte alltid en modig liten kanin, men som tur är har han sin familj som stöttar honom. Hans vänner också, särskilt när professor Varg ställer till med oreda. Då kan till och med Superkaninen Simon och hans gäng komma till undsättning! Webb2 juli 2024 · Simon's two-stage design and the admissible two-stage design have been commonly used in practice for single-arm phase II clinical trials when the primary … how to shine up counter tops
A Rescue Strategy for Handling Unevaluable Patients in Simon’s Two …
WebbThe trial is conducted in two stages with the option to stop the trial after the first or after the second stage (and not recommending the agent for further development). The basic approach is to “minimize” expected sample size when the true response is low - say, less than some pre-determined uninterested level . TWO-STAGE SIMON’S DESIGN http://www.cancer.unc.edu/biostatistics/program/ivanova/SimonsTwoStageDesign.aspx Webb1 mars 1989 · Such trials are often conducted in a multi-institution setting where designs of more than two stages are difficult to manage. ... Biometrics 35:549-555, 1979 11. Lee YJ, Staquet M, Simon R, Cantane R, Muggia F: Two stage plans for patient accrual in phase II cancer clinical trials. Cancer Treat Rep 63:1721-1726, 1979 10 R. Simon 12. notre dame university css code