Proper inference from Simon's two-stage designs

by Tatsuki Koyama

There are many software available for constructing a Simon's design. These software usually give sample sizes and critical values for stages 1 and 2, therefore, hypothesis testing is simple to conduct. Analyzing the data beyond hypothesis testing, however, is not straightforward when a Simon's design is used. When the actual stage 2 sample size is different from the one originally planned, data analysis is even more complicated. Many previously published clinical trials do not correctly account for such mid-course changes.

We present a simple R function for inference from Simon's two stage design: twostage2020Web.R

The method is based on "Proper inference from Simon's two-stage designs" by Koyama and Chen (Statistics in Medicine [2008]).
  • Koyama T, Chen H. Proper inference from Simon's two-stage designs. Stat Med. 2008 Jul 20;27(16):3145-54. doi: 10.1002/sim.3123. PMID: 17960777; PMCID: PMC6047527.

Topic revision: r8 - 05 Aug 2021, TatsukiKoyama

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