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. Author manuscript; available in PMC: 2013 Mar 15.
Published in final edited form as: Clin Trials. 2012 Jul 18;9(4):385–395. doi: 10.1177/1740774512450101

Table 5.

Operating Characteristics for Three Methods: Simon's Adjusted Design (or a Modified Simon-Schultz Procedure), A Flexible Bivariate-Binomial Method Evaluated at Simon's Sample Sizes, and an Optimal Bivariate-Binomial Method.

Method πr0 (%) πs0 (%) n 1 n PET (%) E[Nt | H0] Size (%) Power Hr (%) Power Hs (%)
Simona 5 5 21 41 51 30.7 9.3 91.4 91.4
Flx-Biv 51 30.7 9.3 91.4 91.4
Opt-Biv 21 40 51 30.2 8.6 90.6 90.6
Simona 10 10 21 66 42 47.1 10.4 92.5 92.5
Flx-Biv 42 47.1 7.9 92.4 89.8
Opt-Biv 27 57 52 41.5 9.5 90.7 90.7
Simona 20 20 37 83 47 61.4 9.9 91.5 91.5
Flx-Biv 47 61.4 9.9 91.5 91.5
Opt-Biv 37 78 47 58.7 9.2 90.0 90.0
Simona 30 30 39 100 38 76.7 9.6 91.9 91.9
Flx-Biv 38 76.7 9.6 91.9 91.9
Opt-Biv 49 91 52 69.4 9.4 90.0 90.0
Simona 70 70 25 79 43 55.5 10.3 92.5 92.5
Flx-Biv 43 55.5 8.3 92.3 89.9
Opt-Biv 34 68 54 49.8 9.8 90.6 90.6
Simona 80 80 19 42 58 28.6 9.7 91.6 91.6
Flx-Biv 42 32.4 7.2 85.2 92.2
Opt-Biv 18 43 53 29.7 8.8 91.7 91.7
Simonbc 5 10 21 66 22 56.1 10.0 98.2 94.3
Flx-Biv 26 54.2 9.9 96.8 95.3
Opt-Biv 28 46 58 35.5 9.9 90.8 90.1
Simonb 10 15 30 82 13 75.2 8.7 96.9 95.0
Flx-Biv 46 58.1 9.5 93.0 93.6
Opt-Biv 37 61 58 47.2 9.3 90.6 90.3
Simonb 10 25 37 99 7 94.6 9.5 98.8 94.9
Flx-Biv 48 69.4 9.3 96.3 93.1
Opt-Biv 38 74 54 54.5 9.5 90.2 90.4

Note that Δr = Δs = 0.15, α = β = 0.10

a

Procedure utilized the modified Simon procedure as defined above.

b

Procedure utilized the modified Simon-Schultz method.

c

The Simon-Schultz method recommended always proceeding to the second stage. In this case, we required at least 1 response before proceeding to the second stage.