WebbSimon's 2-stage Phase II design Calculates Optimal and Minimax 2-stage Phase II designs given by Richard Simon Usage ph2simon(pu, pa, ep1, ep2, nmax=100) # S3 method for ph2simon print (x, ...) # S3 method for ph2simon plot (x, ...) Arguments pu unacceptable response rate pa response rate that is desirable ep1 WebbThis paper presents two-stage designs that are optimal in the sense that the expected sample size is minimized if the regimen has low activity subject to constraints upon the …
(PDF) Optimal two-stage designs for phase II
Webb27 mars 2024 · Optimal two-stage designs for phase II clinical trials - PubMed The primary objective of a phase II clinical trial of a new drug or regimen is to determine whether it … Webb• Gehan 2-Stage • Simon 2-Stage Optimal • Simon 2-Stage Minimax • Fleming 1-stage • Gehan-Simon 3-Stage • Randomized Phase 2 • Constant Arc-Sine • Randomized ... Two-stage design with early stopping rule for efficacy or futility. 7 Endpoints • Primary • Secondary • Direct • Surrogate Primary & Secondary Endpoints breaking a fast with a banana
Simon 2-stage function — simon2stage • PhIIdesign
Webb2 be the number of responders in Stage 2 for the biomarker-negative and biomarker-positive sub-populations, respectively. When there is enrichment, let XC 2e be the … WebbThe Simon's two stage design is a commonly used phase II design. ... Zhou, H.*, Lee, J. and Yuan, Y. (2024) BOP2: Bayesian Optimal Design for Phase II Clinical Trials with Simple … Webb12 aug. 2024 · Thus Simon (1989) describes two, two-stage designs with somewhat different properties from those of Gehan. He describes a Phase II design that is 'optimal' … breaking a fast what to eat