Simon's minimax two-stage design
WebbObjective To compare Gehan two-stage design and Simon two-stage design in sample size calculations for phase Ⅱ clinical trials of anti-tumor drugs. Methods We explained the sample size calculation methods with a single-stage design, Gehan two-stage design, and Simon optimal two-stage and minimax two-stage designs in line with the principle of … 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, …
Simon's minimax two-stage design
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Webb2 u (1 p( x 1 d r 1))--- (3) Minimax Design 的目標是希望總樣本數為最小,總樣本數即為以下式(4),故 限制式(1)、(2)再加上使得式(4)為最小的條件來求解。在此設計下所得到的總 … WebbDownloadable! This article describes a new Stata command called simontwostage, which calculates the critical values and sample sizes for two-stage designs for phase II …
Webb略説 Simon's two stage design に対するサンプルサイズ設計を行う Web アプリです、JavaScript で作成しています。 本ソフトウェアは R の clinfun package のアルゴリズム … Webb7 mars 2024 · Calculates Optimal and Minimax 2-stage Phase II designs given by Richard Simon Usage ph2simon(pu, pa, ep1, ep2, nmax=100) ## S3 method for class 'ph2simon' …
Webb描述:计算 Richard Simon 给出的 Optimal 和 Minimax 2 阶段 Phase II 设计. 用法:ph2simon (pu, pa, ep1, ep2, nmax=100) 参数说明:. pu:不可接受的响应率. pa:理想的响应率. ep1:I类错误(alpha,α). ep2:II类错误(beta,β). nmax:最大总样本量(默认为 100;最多为 500). ph2simon ... 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-tumor activities are evident. Conclusion Simon two-stage design is better than single-stage design and Gehan two-stage design.
Webb8 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 …
WebbSimon’s two-stage minimax and optimal designs are widely used for binary endpoint [2–7]. Simon’s designs allow early trial termination due to futility while Fleming’s design allows early trial termination due to futility and superiority in Phase II … flutter text input actionWebbpractically synonymous with the Simon’s optimal and MINIMAX two stage (1989) –designs which have stood the test of time with their pracmatic trade-off between the need to … flutter textinputaction: textinputaction.doneWebbis observed in stage 1, but the DC rate is promising (be-cause many patients had stable disease), we do not want to stop for futility at the interim. Consider the following two … greenheck sp-a125-qdWebb21 okt. 2024 · The Simon two-stage approach involves two criteria, minimax and optimal, for selecting sample sizes and critical values for these two-stage designs. Usually, the … flutter text heightWebbSimonの2段階デザイン(Controlled Clin Trials1989) • 仮説検定の枠組みを用いる • 2つの段階から成る – 第1段階:次相へのno-goを早期に検討する(futility stop) – 第2段階: … greenheck sp-a125 submittalWebbTHE DESIGN • Two stages (the design could have more than two stages, but less practical and not used) • Enroll n. 1 . patients in stage 1; the trial is . stopped. if r. 1 . or fewer … flutter text in column overflowWebbSimon’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 … greenheck sp a125 exhaust fan