Webb28 maj 2024 · Based on Simon two-stage minimax design, 13 patients will be enrolled in Stage 1. If at least one response is noted, the study will proceed to Stage 2 and enroll an additional 14 patients. The null hypothesis will be rejected if 4 or more responses are observed among 27 patients. Webbthree-stage design stopping for ef ficacy [6], admissible designs that balance the optimisation criteria of expected sample size and maximum sample size [8], using a predictive probability design [9], balanced two-stage designs [10],andestimating response rates after using the Simon two-stage design [11].All
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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. … Webb20 nov. 2012 · A Simon’s two-stage minimax design with P 0 =50% and P 1 =65%, α=10% and power=90% using the software by Machin et al (2009) gives the required sample … shanny total commander
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Webb15 dec. 2009 · A Simon two-stage minimax design was used (p 0 =0.1; p 1 =0.3, α=β=0.1) with 16 patients in the first stage and a total of 25 pts. Secondary endpoints included objective response rate and duration of response. Webb26 juli 2024 · Will be assessed using a Simon two-stage minimax design. Secondary Outcome Measures : Progression-free survival (PFS) as measured by irRECIST 1.1 criteria [ Time Frame: Up to 2 years ] Will be assessed using a Simon two-stage minimax design Overall survival (OS) as measured by irRECIST 1.1 criteria [ Time Frame: Up to 2 years ] WebbJung SH, Carey M and Kim KM. (2001). Graphical Search for Two-Stage Designs for Phase II Clinical Trials. Controlled Clinical Trials 22, 367-372. Simon R. (1989). Optimal Two-Stage Designs for Phase II Clinical Trials. Controlled Clinical Trials 10, 1-10. See Also oc.gentwostage.bdry Examples # Two-stage safety design with pu (p0) = 0.33 vs. pa ... shanoah hernandez artesia nm