get_oc_2arm_binary {frequentistSSDBinary}

Generate operating characteristics for Two-Stage Screened Selection Design for Randomized Phase II Trials with Binary Endpoints

Description

Obtain the operating characteristics of Two-Stage Screened Selection Design for Randomized Phase II Trials with Binary Endpoints. The arguments for this function are from outputs of the functions of sample_size_2arm_binary() and optimal_2arm_binary()

Usage

get_oc_2arm_binary(r1, r2, n1, n, p0, p1, p2, diff = 0, nsim, seed = 2483)

Arguments

r1

the maximum number of successes in stage 1 which will terminate trial

r2

the maximum number of successes in stage 2 not to warrant further investigation

n1

the number of subjects in stage 1

n

the total number of subjects (stage 1 + stage 2)

p0

the response rate of historical data

p1

the response rate of arm 1

p2

the response rate of arm 2

diff

the equivalence margin

nsim

the number of simulated trials

seed

the seed. The default value is seed = 2483

Value

get_oc_2arm_binary() 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

Author(s)

Chia-Wei Hsu, Zongheng Cai, Haitao Pan

References

Cai, Z., Pan, H., Wu, J., Hsu, C.W. (2024). Uncontrolled Randomized Screening Selection Design for Pediatric Oncology Trials. Accepted in Book Chapter of "Master Protocol Clinical Trial for Efficient Evidence Generation"

Wu, J., Pan, H., & Hsu, C. W. (2022). Two-stage screened selection designs for randomized phase II trials with time-to-event endpoints. Biometrical Journal, 64(7), 1207-1218

Yap, C., Pettitt, A. & Billingham, L. Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia. BMC Med Res Methodol 13, 87 (2013)

Examples

get_oc_2arm_binary(r1 = 2, r2 = 6, n1 = 11, n = 21, p0 = 0.2,
                   p1 = 0.415, p2 = 0.615, nsim = 100)