Simon's two-stage design
WebbThe Simon two-stage optimal design is often used for phase II cancer clinical trials. A study proceeds to the second stage unless the null hypothesis, that the true tumour response rate is below some specified value, is already accepted at the end of stage one. Webb2 Fortunately, a closed-form solution exists to this problem. Koyama and Chen (2008) produce a method of calculating the exact p-value for a Simon’s two-stage design, and note that this p-value will always be at least as small as the p-value obtained by naively ignoring the interim step of the design (i.e. simply
Simon's two-stage design
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WebbAn optimal stratified Simon two-stage design In Phase II oncology trials, therapies are increasingly being evaluated for their effectiveness in specific populations of interest. Such targeted trials require designs that allow for stratification based on the participants' molecular characterisation. A targeted design proposed by Jones and Holmg … WebbCompared with the Gehan two-stage design, the Simon two-stage design has the advantage of being able to determine an early termination of trials when no or low anti …
Webb22 feb. 2024 · In early phase clinical studies in oncology, Simon's two-stage designs are widely used. The trial design could be made more efficient by stopping early in the … Webb2.2. Study Design This is a Phase 2a, single arm study in subjects with moderate to severe UC. All subjects will receive 500 mg of PF-06480605 intravenously every 2 weeks (Q2W) for a total of 7 doses. The Simon’s two-stage design is …
Webb17 jan. 2012 · The Simon two stage design consists of studying n1 participants in a first stage and the study stops if there are r1 or fewer responders to the intervention. If there … WebbSimon R. (1989). Optimal Two-Stage Designs for Phase II Clinical Trials. Controlled Clinical Trials 10, 1-10. Jung SH, Carey M and Kim KM. (2001). Graphical Search for Two-Stage …
WebbAn optimal stratified Simon two-stage design In Phase II oncology trials, therapies are increasingly being evaluated for their effectiveness in specific populations of interest. …
WebbOptimum Designs Simon (1989) defines two optimum designs. The first is the minimax design which is the design with the smallest N that obeys both error rate constraints. … optic strategy templateWebb1 juli 2024 · Compared with the Gehan two-stage design, the Simon two-stage design has the advantage of being able to determine an early termination of trials when no or low … portia was in which casketWebbThe design is an adaptation of the Simon Two-Stage Design. We provide examples where the adaptation can result in substantial savings in sample size and thus potentially lead to greater efficiency in decision making during the drug development process. MeSH terms Biomarkers / analysis optic strategy visual communication guyWebbSimon’s two-stage design is a clinical trial design with a single arm, a single binary endpoint (usually success/failure), and a single interim look for futility. The design is … portia wassick vtWebb2 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 … optic strategy pdfWebb22 feb. 2024 · We derive confidence intervals based on sample space orderings, and assess the coverage. For various design options, we evaluate the reduction in expected sample size as a function of the true response rate. Our method provides a solution for estimating response rates in case of a non-stochastic curtailment Simon's two-stage … portia waterproof lamphttp://www.cancer.unc.edu/biostatistics/program/ivanova/SimonsTwoStageDesign.aspx optic stuart olson