Description Usage Arguments Value References Examples
Search the type I error or power of a multinomial (response and disease progression) single- or two-stage design under IUT: H_0: p_1 ≤ p_{01} \ AND \ p_2 ≥ p_{02} \ versus \ H_1: p_1 ≥ p_{11} > p_{01} \ OR \ p_2 ≤ p_{12} < p_{02}
1 2 3 4 | UIT.design(method, s1.rej, t1.rej, s1.acc, t1.acc, n1, s2.rej, t2.rej, n2,
s1.rej.delta=0, t1.rej.delta=0, s1.acc.delta=0, t1.acc.delta=0,
s2.rej.delta=0, t2.rej.delta=0, n1.delta=0, n2.delta=0, p0.s, p0.t, p1.s, p1.t,
signif.level = 0.05, power.level = 0.85, output.all = FALSE, show.time = TRUE)
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method |
design methods according to number of stage and stopping rule, "s1" represents single-stage design stopping for both efficacy and futility, "s2" represents two-stage design stopping for both efficacy and futility, "s2.f" represents two-stage design stopping for futility only. |
s1.rej |
first stage responses threshold to stop the trial for efficacy. Applied for "s1" or "s2". |
t1.rej |
first stage disease progressions threshold to stop the trial for efficacy. Applied for "s1" or "s2". |
s1.acc |
first stage responses threshold to stop the trial for futility. Applied for "s2" or "s2.f". |
t1.acc |
first stage disease progressions threshold to stop the trial for futility. Applied for "s2" or "s2.f". |
n1 |
first stage sample size. Applied for "s1", "s2" or "s2.f". |
s2.rej |
second stage responses threshold to stop the trial for efficacy. Applied for "s2" or "s2.f". |
t2.rej |
second stage disease progressions threshold to stop the trial for efficacy. Applied for "s2" or "s2.f". |
n2 |
second stage sample size. Applied for "s2" or "s2.f". |
s1.rej.delta |
pre-specified search difference for s1.rej. |
t1.rej.delta |
pre-specified search difference for t1.rej. |
s1.acc.delta |
pre-specified search difference for s1.acc. |
t1.acc.delta |
pre-specified search difference for t1.acc. |
s2.rej.delta |
pre-specified search difference for s2.rej. |
t2.rej.delta |
pre-specified search difference for t2.rej. |
n1.delta |
pre-specified search difference for n1. |
n2.delta |
pre-specified search difference for n2. |
p0.s |
pre-specified response rate under null hypothesis. |
p0.t |
pre-specified disease progression rate under null hypothesis. |
p1.s |
pre-specified response rate under alternative hypothesis. |
p1.t |
pre-specified disease progression rate under alternative hypothesis. Note: type I error calculation needs to take maximum of the power function with (p.s,p.t)=(p_{01},0) and (p.s,p.t)=(1-p_{02},p_{02}) |
signif.level |
pre-specified significant level. |
power.level |
pre-specified power level. |
output.all |
logical; if TRUE, output all possible designs satisfying type I error and power restrictions, otherwise, only output the design with maximum power . |
show.time |
logical; if TRUE (default), show the calculation time for the search function. |
boundset |
the boundaries set satisfying the design types properties: s.rej, t.rej and N for "s1", s1.rej, t1.rej, s1.acc, t1.acc and N1 for first stage and s2.rej, t2.rej and N2 for the second stage of "s2", s1.acc, t1.acc and N1 for first stage and s2.rej, t2.rej and N2 for the second stage of "s2.f", |
Zee, B., Melnychuk, D., Dancey, J., & Eisenhauer, E. (1999). Multinomial phase II cancer trials incorporating response and early progression. Journal of biopharmaceutical statistics, 9(2), 351-363.
Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled clinical trials 10(1), 1-10.
1 2 3 4 5 6 7 | ## Calculate type I error for single-stage design
UIT.design(method="s1",s1.rej=18, t1.rej = 12, n1=80,
p0.s = 0.15, p0.t = 0.25, p1.s = 0.3, p1.t= 0.1)
## Designs for two-stage design, output PET and EN under null hypothesis
UIT.design(method="s2",s1.rej = 11, t1.rej = 4, s1.acc=8, t1.acc = 5, n1=40,
s2.rej=18, t2.rej = 11, n2=40, p0.s = 0.15, p0.t = 0.25, p1.s = 0.3, p1.t= 0.1, output.all=TRUE)
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