Table 5.
Optimal two-stage parameters for designs that minimize either the ETSL (top line) or the EDA (bottom line) for testing H0: S(1) ≤ .35. Power is specified for S(1) = .5.#
α | 1 - β | DA/x* | t1 | C1 | C2 | I1/Imax | EDA | MDA | ETSL | MTSL |
.1 | .9 | 1.50 | 1.01 | .488 | 1.154 | .49 | 1.05 | 1.15 | .76 | 1.09 |
.81 | -.489 | 1.257 | .32 | .96 | 1.03 | .85 | 1.02 | |||
1.75 | .93 | .457 | 1.159 | .48 | 1.00 | 1.15 | .76 | 1.10 | ||
.76 | -.291 | 1.245 | .34 | .94 | 1.05 | .82 | 1.03 | |||
2 | .87 | .434 | 1.163 | .47 | .96 | 1.15 | .75 | 1.10 | ||
.72 | -.179 | 1.237 | .36 | .92 | 1.06 | .80 | 1.04 | |||
3 | .74 | .375 | 1.172 | .46 | .88 | 1.15 | .75 | 1.11 | ||
.63 | .004 | 1.220 | .38 | .86 | 1.09 | .77 | 1.07 | |||
4 | .67 | .346 | 1.176 | .45 | .84 | 1.15 | .75 | 1.12 | ||
.59 | .073 | 1.212 | .39 | .83 | 1.10 | .76 | 1.08 | |||
.05 | .95 | 1.50 | .99 | .680 | 1.536 | .46 | 1.03 | 1.17 | .72 | 1.10 |
.81 | -.274 | 1.622 | .32 | .95 | 1.04 | .81 | 1.02 | |||
1.75 | .91 | .648 | 1.541 | .46 | .98 | 1.16 | .72 | 1.10 | ||
.75 | -.084 | 1.612 | .34 | .92 | 1.06 | .78 | 1.04 | |||
2 | .85 | .624 | 1.545 | .45 | .94 | 1.16 | .71 | 1.11 | ||
.72 | .024 | 1.605 | .35 | .89 | 1.07 | .76 | 1.05 | |||
3 | .72 | .563 | 1.553 | .44 | .85 | 1.16 | .71 | 1.12 | ||
.63 | .202 | 1.591 | .38 | .83 | 1.10 | .72 | 1.08 | |||
4 | .66 | .531 | 1.557 | .44 | .80 | 1.15 | .70 | 1.12 | ||
.59 | .266 | 1.586 | .39 | .79 | 1.11 | .71 | 1.09 |
# DA is the fixed sample duration of accrual; x* is the survival time of interest; t1 is the time of the first interim review; C1 and C2 are the cutpoints for acceptance at the first stage and rejection at the second stage; I1 and Imax are the information available at the interim and final reviews; EDA and MDA are the expected and maximum duration of accrual relative to the single stage values; and ETSL and MTSL are the expected and maximum total study length relative to the single stage values. Expected values are calculated under the null hypothesis.