Simon's two-stage design
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 …
Simon's two-stage design
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Webb22 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 …
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 … WebbThe 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
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 … 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 …
WebbAbstract 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 second …
WebbThis function calculates the sample size needed in a Simon 2-stage design which is a two-stage design that is optimal in the sense that the expected sample size is minimized if … darth rivixWebb27 maj 2024 · For adaptive phase II clinical trials with binary endpoint, the Simon's two stage design is well-known (Simon 1989) and easy to implement. However, I was wondering, whether there are multi-arm two-stage extensions to this design and if there exist any implementations in statistical software packages (preferably in R)? bissonet and riceWebb3 juli 2013 · The Screened Selection Design involves first applying Simon’s two-stage design [ 3] in each of the two parallel experimental arms, which allows for initial determination of efficacy and early stopping for futility in any of the arms. bisson evelyneWebb20 maj 2024 · In both Simon’s and Fleming’s two-stage designs, the maximum sample size of admissible design is smaller than optimal design but larger than minimax design. … darthrodrickWebb28 juli 2024 · Among the candidate two-stage designs, the Simon’s (1986) minimax design has the smallest maximal sample size n and the optimal design has the smallest expected sample size under H0 : p = p0, EN(p0). Minimax Design vs. Optimal Design. When designing a two-stage phase II trial with input parameters (p0, p1, α∗, 1 - β∗), one often ... dar thrift store salem scWebb8 juni 2024 · Simon’s two-stage design (Simon, 1989) is still one of the most often used designs in oncology phase 2 trials in single-arm trials testing a binary endpoint. After n1 patients (stage 1) the trial is … bissonette houston bWebbMultiple-stage designs including two-stage and three-stage have been developed by several authors. For example, Simon's optimal two-stage design [Simon R. Optimal two-stage designs for phase II clinical trials. bisson family history