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. Author manuscript; available in PMC: 2020 Jan 14.
Published in final edited form as: J Biopharm Stat. 2019 Apr 24;30(1):69–88. doi: 10.1080/10543406.2019.1607368

Table 3.

Impact of time-trend on operating characteristics of BRAR with early stopping rule maximum sample size=302, burn-in size=50, allocation update frequency=28, Efficacy stop=0.99

Randomization algorithm Efficacy profile Trend pattern Sample size Efficacy stopping in favor of Arm 1 Arm 2 % better arm (SD) Bias(SD)
Fixed equal (1:1) P1=P2=0.3 δ1=0, δ2=0 289 (51) 0.04 0.036 0.50 (0.031) 0.0007(0.084)
δ1=0.1, δ2=0.1 289 (50) 0.038 0.037 0.50 (0.031) 0.0009(0.083)
δ1=0.2, δ2=0.2 289 (49) 0.039 0.036 0.50 (0.031) 0.0008(0.084)
δ1=0, δ2=0.1 286 (52) 0.023 0.087 0.50 (0.032) −0.047 (0.083)
P1=0.4, P2=0.3 δ1=0, δ2=0 246 (84) 0.382 0.001 0.50 (0.036) 0.029 (0.096)
δ1=0.1, δ2=0.1 246 (85) 0.371 0.002 0.50 (0.037) 0.029 (0.099)
δ1=0.2, δ2=0.2 246 (85) 0.374 0.002 0.50 (0.036) 0.029 (0.097)
δ1=0, δ2=0.1 260 (82) 0.237 0.002 0.50 (0.035) −0.014(0.108)
P1=0.5, P2=0.3 δ1=0, δ2=0 148 (81) 0.899 0 0.50 (0.048) 0.044 (0.094)
δ1=0.1, δ2=0.1 147 (82) 0.895 0 0.50 (0.048) 0.049 (0.097)
δ1=0.2, δ2=0.2 149 (83) 0.887 0 0.50 (0.049) 0.047 (0.097)
δ1=0, δ2=0.1 164 (95) 0.767 0 0.50 (0.047) 0.028 (0.112)
BRAR(n/2N) P1=P2=0.3 δ1=0, δ2=0 289 (50) 0.034 0.038 0.50 (0.077) −0.0014 (0.083)
δ1=0.1, δ2=0.1 288 (50) 0.04 0.046 0.50 (0.079) −0.0008 (0.089)
δ1=0.2, δ2=0.2 286 (52) 0.058 0.055 0.50 (0.082) −0.0002 (0.098)
δ1=0, δ2=0.1 286 (51) 0.025 0.09 0.47 (0.075) −0.048 (0.085)
P1=0.4, P2=0.3 δ1=0, δ2=0 248 (84) 0.355 0.001 0.58 (0.064) 0.028 (0.094)
δ1=0.1, δ2=0.1 244 (84) 0.411 0.002 0.58 (0.065) 0.037 (0.096)
δ1=0.2, δ2=0.2 238 (85) 0.469 0.003 0.57 (0.065) 0.046 (0.097)
δ1=0, δ2=0.1 260 (81) 0.241 0.002 0.56 (0.069) −0.010 (0.108)
P1=0.5, P2=0.3 δ1=0, δ2=0 150 (84) 0.874 0 0.56 (0.067) 0.046 (0.097)
δ1=0.1, δ2=0.1 145 (80) 0.909 0 0.56 (0.067) 0.052 (0.092)
δ1=0.2, δ2=0.2 143 (77) 0.928 0 0.56 (0.065) 0.054 (0.091)
δ1=0, δ2=0.1 163 (95) 0.772 0 0.57 (0.070) 0.032 (0.109)
BRAR(1/2,σ2) P1=P2=0.3 δ1=0, δ2=0 290 (47) 0.036 0.034 0.50 (0.095) 0.0008 (0.082)
δ1=0.1, δ2=0.1 288 (51) 0.047 0.044 0.50 (0.096) 0.0013 (0.091)
δ1=0.2, δ2=0.2 284 (55) 0.061 0.061 0.50 (0.099) 0.0002 (0.101)
δ1=0, δ2=0.1 287 (51) 0.024 0.09 0.46 (0.093) −0.048 (0.086)
P1=0.4, P2=0.3 δ1=0, δ2=0 251 (82) 0.344 0.003 0.61(0.076) 0.029 (0.097)
δ1=0.1, δ2=0.1 245 (84) 0.396 0.002 0.61 (0.076) 0.037 (0.097)
δ1=0.2, δ2=0.2 239 (85) 0.453 0.003 0.61 (0.076) 0.045 (0.100)
δ1=0, δ2=0.1 260 (80) 0.24 0.004 0.59 (0.083) −0.009 (0.110)
P1=0.5, P2=0.3 δ1=0, δ2=0 157 (86) 0.858 0 0.63 (0.078) 0.046 (0.097)
δ1=0.1, δ2=0.1 150 (83) 0.89 0 0.62 (0.080) 0.054 (0.096)
δ1=0.2, δ2=0.2 144 (78) 0.919 0 0.62 (0.077) 0.059 (0.091)
δ1=0, δ2=0.1 170 (96) 0.747 0 0.62 (0.079) 0.030 (0.110)
BRAR(1/2) P1=P2=0.3 δ1=0, δ2=0 290 (49) 0.032 0.038 0.50 (0.129) −0.0022 (0.086)
δ1=0.1, δ2=0.1 287 (52) 0.049 0.05 0.50 (0.135) 0.0001 (0.096)
δ1=0.2, δ2=0.2 283 (55) 0.069 0.07 0.50 (0.138) −0.0016 (0.107)
δ1=0, δ2=0.1 287 (50) 0.023 0.085 0.46 (0.128) −0.049 (0.088)
P1=0.4, P2=0.3 δ1=0, δ2=0 255 (81) 0.316 0.002 0.64 (0.102) 0.028 (0.096)
δ1=0.1, δ2=0.1 246 (83) 0.394 0.003 0.64 (0.100) 0.041 (0.096)
δ1=0.2, δ2=0.2 237 (84) 0.481 0.003 0.64 (0.102) 0.053 (0.098)
δ1=0, δ2=0.1 262 (79) 0.232 0.004 0.62 (0.111) −0.007 (0.110)
P1=0.5, P2=0.3 δ1=0, δ2=0 162 (90) 0.82 0 0.65 (0.099) 0.046 (0.096)
δ1=0.1, δ2=0.1 153 (84) 0.882 0 0.65 (0.098) 0.054 (0.091)
δ1=0.2, δ2=0.2 146 (79) 0.917 0 0.64 (0.096) 0.060 (0.088)
δ1=0, δ2=0.1 176 (98) 0.712 0 0.65 (0.101) 0.029 (0.110)