frequentistSSD (version 0.1.1)

get_oc: Generate operating characteristics for Two-Stage Screened Selection Design for Randomized Phase II Trials with Time-to-Event Endpoints

Description

Obtain the operating characteristics of Two-Stage Screened Selection Design for Randomized Phase II Trials with Time-to-Event Endpoints. The arguments for this function are from outputs of the functions of optimal() and sample_size()

Usage

get_oc(shape, m0, mA, hr, frac, ta, tf, c1, c,
       diff, n, nsim, seed = 2483)

Arguments

shape

the shape parameter of weibull distribution

m0

the median survival time of historical data

mA

the median survival time of arm A

hr

the hazard ratio of arm B to arm A

frac

the ratio of sample size in stage 1 compared to total sample size (e.g., n1/n)

ta

the accrual duration

tf

the follow-up duration

c1

the critical value at stage 1

c

the critical value at stage 2

diff

the equivalence margin

n

the total sample size for each arm

nsim

the number of simulated trials

seed

the seed. The default value is seed = 2483

Value

get_oc() returns: (1) n: total sample size for each arm (2) SSD.Arm.A: selection probability of Arm A (3) SSD.Arm.B: selection probability of Arm B (4) SSD.No.Arm: the probability of no arms selected (5) diff: the equivalence margin (6) Mean.N.Arm.A: the average number of patients allocated to Arm A (7) Mean.N.Arm.B: the average number of patients allocated to Arm B

References

Jianrong Wu, Haitao Pan, Chia-Wei Hsu (2021). "Two-Stage Screened Selection Designs for Randomized Phase II Trials with Time-to-Event Endpoints." Submitted

Examples

# NOT RUN {
## c1, n, c they all come from optimal function. Details are shown as follows:
# }
# NOT RUN {
optimal(shape = 1, m0 = 1, ms = 2.4, tf = 3,
                 ta = 24, tot_size = 19, dist = "WB")
| alpha | beta | n1 |   c1   |  n |    c   |   t1    | MTSL |   ESS   |   PS
|  0.05 | 0.08 | 15 | 0.0508 | 19 | 1.6434 | 17.9751 |  27  | 16.5183 | 0.5203
# }
# NOT RUN {
get_oc(shape = 1, m0 = 1, mA = 2.4, hr = 0.6, frac = 15/19,
       ta = 24, tf = 3, c1 = 0.0508, c = 1.6434,
       diff = 0.25, n = 19, nsim = 10000)
# }