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. Author manuscript; available in PMC: 2013 Aug 15.
Published in final edited form as: Clin Cancer Res. 2012 Jun 14;18(16):4225–4233. doi: 10.1158/1078-0432.CCR-12-0686

Table 3.

Comparison of Operating Characteristics for a Design with direct assignment option vs. a Balanced randomized design. 6,000 trial simulations; 1-β = 0.80; pcontrol = 0.20, Stage I analysis at half of accrual (f=0.50); Total sample size planned N = 101 and 65 for α = 0.10 and 0.20, respectively.

α = 0.10 α = 0.20
Response
Rate Ratio
(ptreat /
pcontrol)		 Balanced
Randomized
Design		 Design with
Direct
Assignment
Option		 Balanced
Randomized
Design		 Design with
Direct
Assignment
Option
Power (%) 2.00 80.6 79.3 79.3 78.0
2.25 90.5 89.0 88.0 86.3
2.50 96.5 95.5 94.5 93.2
3.00 99.7 99.3 99.0 98.7
Type I Error Rate (%) - 10.4 11.5 19.7 21.8